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Sinsin Pharmaceutical Co., Ltd. - 718720 - 11/12/2025

WARNING LETTER November 12, 2025 RE: 718720 Hyun-Kwang Dan: This letter is to advise you that on April 15, 2025, the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website at www.sinsinpas.us/, which directs consumers to your Amazon storefront where your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS drug products are available for purchase in the United States without a prescription. We also reviewed your social media on Facebook and Instagram at https://www.facebook.com/search/top?q=sinsinpas_us and https://www.instagram.com/sinsinpas_us, which also direct consumers to your Amazon storefront. SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below. Unapproved New Drug and Misbranded Drug Violations SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Examples from the SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS product labeling, including your website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following: SINSINPAS AREX INSTANT PAIN RELIEF “Drug Facts... Purpose: Topical Analgesic... Uses For temporary relief of minor aches and pains of muscles and joints associated with: ■ Arthritis ■ Simple Backache ■ Strains ■ Bruises ■ Sprains,” “- Joint Pain – Muscle pain – Sprains – Backache” [from the product label] SINSINPAS Pain Relieving Liquid MULPAS “Drug Facts... Purpose: Topical Analgesic... Uses For temporary relief of minor aches and pains associated with: ■ arthritis ■ simple backache ■ sprains ■ strains ■ bruises”; “Muscle Pain Arthritis Strains Insect Bites” [from the product label] Unapproved New Drug Violations Based on the above labeling evidence SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are intended for use as external analgesic drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products identified above. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription external analgesic drug products, such as your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS, in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph, here External Analgesic Drug Products for Over-the-Counter Human Use (hereafter M017).1 However, SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS do not conform to the conditions specified in M017 for the reasons described below. Your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are formulated with active ingredients that are not permitted for OTC external analgesic drug products under M017.12. Specifically, according to your product’s labeling, your SINSINPAS AREX INSTANT PAIN RELIEF product is formulated with the active ingredients zinc oxide and mentha oil. However, zinc oxide and mentha oil are not permitted active ingredients under M017.12 when used in combination, or as sole ingredients, for any OTC external analgesic drug product. In addition, your SINSINPAS Pain Relieving Liquid MULPAS is formulated with the active ingredients chlorpheniramine maleate and thymol. However, chlorpheniramine maleate and thymol are not permitted active ingredients under M017.12 when used in combination, or as sole ingredients, for any OTC external analgesic drug product. Furthermore, FDA has also determined that OTC external analgesic and anesthetic drug products with the active ingredient thymol are not generally recognized as safe and effective (GRASE) under a final determination issued under 21 CFR par 330.2 Thus, your SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS products do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.3 Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application. Because there are no approved applications in effect for these products, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Misbranded Drug Violations Additionally, SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355. The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Conclusion The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “718720” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration ____________________ 1 M017 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000033, available at FDA’s website OTC Monographs@FDA https://dps.fda.gov/omuf. 2 Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses. See Order ID OTC000007, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.

Siddha Flower Essences, LLC., dba Siddha Remedies - 713217 - 11/04/2025

Warning Letter 320-26-14 November 4, 2025 Dear Mr. Deland: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Siddha Flower Essences, LLC., dba Siddha Remedies, FEI 3014145088, at 2350 Eastman Ave., Suite 107, Oxnard, from April 22 to 29, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your human and animal drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). In addition, we reviewed your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS) and found that you failed to update your human over-the-counter (OTC) homeopathic drug listings as required under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207. Thus, your drugs are not properly listed, and your firm has not fulfilled its listing obligations under 510(j) of the FD&C Act, U.S.C. 360(j), and 21 CFR 207, which is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p), and will render a drug misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below. We reviewed your May 20, 2025 response to our Form FDA 483 in detail. During our inspection, our investigator observed specific violations including, but not limited to, the following. CGMP Charges 1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals. Your firm also failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use (21 CFR 211.84(d)(1) and 211.84(d)(2)) and (21 CFR 211.84(d)(6)). You manufacture aqueous oral homeopathic drug products intended for children as young as 2 years old. Purified Water You failed to test your purchased bulk water to assure it was of acceptable quality for use in drug production. You also failed to establish the reliability of your component supplier at appropriate intervals. Your firm has not demonstrated that the water was suitable for its intended use and minimally met the USP purified water monograph. Pharmaceutical-grade water must be suitable for its intended use. Each lot must be tested to ensure conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts as well as characterization and identification of contamination is integral to ensuring water is of acceptable quality for use in manufacturing operations. Of particular note, you stopped testing the water after 2022, but you continued to use it as a component of your pediatric drug products. Prior to stopping, you did not test the water for Burkholderia cepacia complex (BCC), a contamination risk in non-sterile water-based drug products, which has been linked to multiple instances of opportunistic infections. For further information regarding the significance of BCC and other objectionable contamination of non-sterile, water-based drug products, see FDA’s advisory notice, at https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-drug-manufacturers-burkholderia-cepacia-complex-poses-contamination-risk-non-sterile. Botanical You also failed to perform adequate testing of botanical components that may pose potentially toxic effects. Without adequate component controls, you lack scientific evidence to assure component identity, safety, quality, and conformance to appropriate specifications. In your response, you acknowledge insufficient expertise, quality unit (QU) oversight, and resources. You also commit to improving component controls (e.g., specifications, procedures, testing) and propose various timelines for completion. However, you did not provide clear interim plans for drug production until corrections are completed. Also, you have not confirmed the reliability of your contract testing laboratories, nor have you evaluated the impact of using inadequately controlled components on the quality and safety of drug products distributed within the United States. In response to this letter, provide: A comprehensive, independent review of your material system including, but not limited to: o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified o an assessment of all materials to determine whether they are consistently of acceptable quality o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions o a summary of your systemic corrective action and preventive action (CAPA) to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures. The chemical and microbiological quality control specifications you use to test and release each incoming lot of the components you use in manufacturing and corresponding test results (e.g., total counts, identification to detect objectionable microbes, such as BCC). A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificates of analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture. 2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You failed to adequately investigate finished drug product sample results that were out of limit (OOL) for microbiological contamination. For example, you failed to identify a root cause and implement adequate CAPA. You state that you have rejected and destroyed the contaminated batch, however, you could not provide supporting documentation. You also failed to characterize and identify gram-negative growth recovered in finished drug product samples to evaluate whether it is objectionable based on intended use. Microbiological contamination of aqueous drug products poses an unacceptable risk to children as gram-negative bacteria have been linked to opportunistic infections. In your response, you state your firm lacks qualified personnel and has insufficient QU oversight and resources. You also commit to performing CAPA including a retrospective review of discrepancies for potential product impact. However, your response in inadequate. You did not provide a clear timeline for CAPA completion (e.g., BCC testing) or clear interim plans for drug production until you determine the full scope of impact to drug quality and safety. Well-documented, thorough, and scientifically sound investigations are necessary to identify the root cause and implement appropriate and effective CAPA. In response to this letter, provide: A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations, with a detailed and thorough review of all microbiological hazards. A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls. Complete investigations of all batches with potential objectionable microbial contamination or an out-of-limit (OOL) microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination. Appropriate microbiological batch release specifications (e.g., total counts, identification of bioburden to detect objectionable microbes, such as BCC) for each of your drug products including the specific date test results indicated drug products met all specifications. All chemical and microbial test methods used to analyze each of your drug products. A summary of results from testing retain samples of all drug product batches within expiry. You should test all appropriate quality attributes including, but not limited to, microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOS result, indicate the corrective action you will take, including notifying customers and initiating recalls. A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted. 3. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)). Your firm released finished drug product Temper Tamer lot# S22-26424D without testing for critical microbial attributes (e.g., total count, absence of objectionable microorganisms). Without testing each batch prior to release, you did not have scientific evidence that all oral drug product batches were free of objectionable microbial contamination. In particular, your firm failed to conduct testing for BCC for non-sterile aqueous-based drug products at release and on stability. See FDA’s advisory notice mentioned above. In addition, see FDA’s guidance document, Microbiological Quality Considerations in Non-sterile Drug Manufacturing, for help minimizing the risks of harmful microbiological contamination of aqueous drugs at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/microbiological-quality-considerations-non-sterile-drug-manufacturing. We acknowledge that you voluntarily initiated a recall of pediatric drug product Temper Tamer lot# S22-26424D on April 28, 2025. However, it is important to note that this CGMP violation was identified by your firm as a result of an FDA inspection conducted from April 25 to 29, 2025. In your response, you acknowledge insufficient QU oversight, lack of qualified personnel, and lack of adherence to procedures. You also commit to improving finished product controls (e.g., specifications, procedures, testing), conducting a retrospective review, and proposing various completion dates. However, several details remain unclear. This includes, but is not limited to, a clear timeline for CAPA completion (e.g., BCC testing) and interim plans for your operations while you determine the full scope of the impact of your violations on the quality and safety of the drugs you produce. In response to this letter, provide: A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision. o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter. o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective action, such as notifying customers and product recalls. 4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your QU did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure: Established procedures were followed (21 CFR 211.22(d)) Batch records were reviewed before drug product release (21 CFR 211.22(a)) Use of qualified contract testing laboratories (21 CFR 211.22(a)) Adequate effectiveness testing of the preservative system (21 CFR 211.160(b)) Adequate production and process controls were established (21 CFR 211.100(a)) Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations. In response to this letter, provide: A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to: o A determination of whether procedures used by your firm are robust and appropriate o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices o A complete and final review of each batch and its related information before the QU disposition decision Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products A description of how top management supports quality assurance and reliable operations including, but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control. A comprehensive, independent assessment of your change management system. This assessment should include, but not be limited to, your procedure(s) to ensure changes are justified, reviewed, and approved by your quality unit. Your change management program should also include provisions for determining change effectiveness. Establishment Registration and Drug Listing Violations Section 510 of the FD&C Act, 21 U.S.C. 360, and 21 CFR Part 207 set forth the requirements for the registration of establishments and listing of drugs. Under 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR 207.57(b), registrants are required to update drug listing information twice each year, in June and December. Under 21 CFR 207.57(b)(2) registrants may satisfy the listing update requirement with respect to unchanged listing information by making a single “no changes” certification during the October 1st through December 31st annual registration period. If the drug listing data is not updated or certified, the outdated listing data will be inactivated at the next scheduled FDA inactivation period.1 You failed to update or certify your human OTC homeopathic drug listings as required. Therefore, your human OTC homeopathic drugs are not properly listed under section 510(j) of the FD&C Act, rendering these drugs misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). In addition, failure to properly list a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Establishment registration and drug listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education. We note that during the inspection, your firm was notified that your human OTC homeopathic drugs were listed as “Inactivated-Uncertified” in eDRLS, and you have failed to update these drug listings. If you cease manufacturing and distributing any drug, then you must discontinue that listed drug in eDRLS by adding an end marketing date which corresponds to the expiration date of the last lot in commercial distribution. It is your responsibility to ensure that all drugs manufactured at your establishment comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found at Electronic Drug Registration and Listing Instructions. Sections 510(b)(1) and (j)(1) of the FD&C Act [21 U.S.C. 360(b)(1), (j)(1)] require that manufacturers of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drugs they manufacture. Drugs that are manufactured in an establishment that is not duly registered or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act. You have been manufacturing animal drugs in a facility that is not registered with FDA as an animal drug manufacturer. Further, you have incorrectly listed your animal drug products under the human drug establishment registration. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act. CGMP Consultant Recommended Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective action and preventive action before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. Use of Contract Manufacturers Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer. You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry. Conclusion The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations. This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3014145088 and ATTN: CDR Matthew Schnupp, PharmD, BCSCP. Sincerely, /S/ Jill P. Furman, J.D. Director Office of Compliance Center for Drug Evaluation and Research /S/ Dillard H. Woody Jr. Acting Director Division of Drug Compliance Office of Surveillance & Compliance Center for Veterinary Medicine ______________________

123Herbals - 719198 - 11/13/2025

WARNING LETTER November 13, 2025 RE: 719198 Anthony Trinh: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.123herbals.com from July 2025 to November 2025. The FDA has observed that your website offers various products including, “SILINTAN,” “Ganoderma Huo Luo Dan,” “Hong Kong Vail Bon Tong,” “SAM NHUNG BO THAN,” “TDCARE,” and “Vall Boon Antacid” for sale in the United States. In addition, FDA has obtained a sample of your “SILINTAN” product. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Furthermore, your “SILINTAN” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a). FDA confirmed through laboratory analysis that a sample of your “SILINTAN” product contains the undeclared active pharmaceutical ingredient meloxicam. Meloxicam is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. Unapproved New Drugs Based on a review of your website, your “SILINTAN,” “Ganoderma Huo Luo Dan,” “Hong Kong Vail Bon Tong,” “SAM NHUNG BO THAN,” “TDCARE,” and “Vall Boon Antacid” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: SILINTAN On the webpage https://123herbals.com/collections/frontpage/products/silantin-gout-joint-arthritis-supplements?variant=48198515425580: • “SILINTAN 100% natural herbal to relief gout, joint, arthritis body aches [sic].” Ganoderma Huo Luo Dan On the webpage https://123herbals.com/collections/frontpage/products/ganoderma-huo-luo-dan-arthritis-stiff-joints-gout-hot-item: • “Ganoderma Huo Luo Dan for relief of Rheumatism, Gout, Arthritis, Stiff Joints, Back Pains.” Hong Kong Vail Bon Tong On the webpage https://123herbals.com/collections/frontpage/products/hong-kong-vail-bon-tong-cough-herbals-capsules: • “Non Drowsy Treatment of acute or chronic bronchitis, Coughs due to colds, chronic coughs, sore throats, excessive sputum or phlegm.” SAM NHUNG BO THAN On the webpage https://123herbals.com/collections/frontpage/products/kian-pee-wan-appetite-stimulant: • “SAM NHUNG BO THAN herbal supports kidney tonic to nourish blood to improve physiological functions. Improve the symptoms of numb limbs, back pains, relief knee pain due to kidney failure. Relief of Urinary Tract Infection(UTI) symptoms. Support kidney health and limit urged to urinate at night.” TDCARE On the webpage https://123herbals.com/collections/frontpage/products/korean-red-ginseng-made-in-korea-buy3-get1-more-free-plus-free-shipping: • “TDCARE helps to lower blood glucose and cholesterol. Prevents diabetic complications by lowering blood glucose. Lowers cholesterol to prevent cardiovascular disease.” Vall Boon Antacid On the webpage https://123herbals.com/collections/frontpage/products/antacid-tablets-606: • “VALL BOON ANTACID herbals For Use: Gastric pain, Dyspepsia, Bloating, Flatulence, Heartburn, Indigestion.” Your “SILINTAN,” “Ganoderma Huo Luo Dan,” “Hong Kong Vail Bon Tong,” “SAM NHUNG BO THAN,” “TDCARE,” and “Vall Boon Antacid” products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Misbranded Drug Your “SILINTAN” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account... not only representations made or suggested... but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “SILINTAN” product does not declare that the product contains meloxicam. As previously mentioned, this undeclared ingredient in your “SILINTAN” product may pose serious health risks because consumers with underlying medical issues may take the product without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. The failure to disclose this ingredient in the product labeling renders your “SILINTAN” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Your “SILINTAN” product is not the first product found by FDA to contain hidden ingredients. You previously sold the product “Vail-Bon Jie Yang Wan,” which FDA laboratory testing identified as containing undeclared dexamethasone and chlorpheniramine.1 In addition, you market other products on your website that are intended for pain relief, similar to “SILINTAN.” While the Agency has not sampled and tested these products from your inventory to date, this letter is to emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws. Conclusion The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “719198” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration ____________________

Cdymax India Pharma Private Limited - 715022 - 11/13/2025

Warning Letter 320-26-18 November 13, 2025 Dear Ms. Avinash: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cdymax (India) Pharma Private Limited, FEI 3009882550, at 77d & 116/117, KIADB Industrial Area, Jigani, Bangalore, Karnataka, from April 21 to 25, 2025. This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). We reviewed your May 15, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigator observed specific deviations including, but not limited to, the following. 1. Failure to adequately investigate and document out-of-specification results and implement appropriate corrective actions. Your firm manufactures APIs for incorporation into application drug products, including those intended for use in (b)(4) drug products for parenteral administration. You failed to adequately investigate multiple out-of-specification (OOS) results and laboratory incidents during the testing of various samples, including raw materials, starting materials, and stability samples. Since 2023, your firm has experienced approximately 1,500 laboratory incidents involving OOS results and other significant analytical events (e.g., equipment failures). There were numerous examples where your investigations were inadequate, and often lacked thorough root cause analysis, and appropriate corrective actions and preventive actions (CAPAs). In addition, your firm frequently failed to investigate these laboratory incidents as “OOS results,” as specified by your own procedures. Several laboratory incidents without conclusive laboratory root causes lacked sufficient or no manufacturing investigations. For example, your firm initiated a laboratory incident in which test results from two sample preparations of a stability sample for (b)(4) crude failed to meet specification limits for an “unknown peak.” Your firm retested these sample preparations in their original vials and in new sample vials. The results of all four retests were also OOS for an “unknown peak.” Subsequently, you performed a third test with fresh sample preparations and after receiving passing results, your firm invalidated all earlier test results. Your investigation concluded that the unknown peaks “could be due to sample solution contamination during preparation.” However, the investigation lacked scientific and thorough root cause analysis, failing to identify the contaminant, its origin, or the cause of its presence within your samples. Because you did not determine a definitive laboratory error, your investigation should have included a manufacturing investigation. Additionally, your corrective action of providing “refresher training for personnel on good laboratory practice” contradicted the investigation’s own initial finding that the analyst was trained and qualified to perform the HPLC test according to your procedure. We note that this batch of (b)(4) remains within U.S. distribution and is only one example out of numerous inadequate investigations observed during our inspection. In your response, you provided updated procedures and a risk assessment regarding the investigations identified by our investigator, concluding that the laboratory incidents posed no risk to patients and had no impact on product quality. However, your response contains inconsistencies. For example, you state that you reviewed the incidents and concluded that “none of the batches were released to market by repeating the analysis using a new sample solution preparation.” However, you also provided summarized data tables with column headers labeled “justification for repeat analysis using new sample solution preparation.” Your response is inadequate. Your response lacked evidence that your firm has remediated your systems to better evaluate whether suspected laboratory causes are valid and investigate potential manufacturing causes where laboratory errors have not been clearly established. Inadequate investigations can result in unidentified root causes, ineffective CAPAs, and recurring problems that compromise your ability to manufacture safe and effective APIs. In response to this letter, provide: A comprehensive, independent assessment of your overall system for investigating deviations, laboratory incidents, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted. An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality unit decisions, and is fully supported by executive management. A retrospective, independent review of all laboratory incidents and OOS results (including in-process and release/stability testing) for U.S. products irrespective of whether the batch was ultimately distributed in the United States for the last four years from the initial date of inspection and a report summarizing the findings of the analysis, including the following for each laboratory incident and OOS: o Determine whether the scientific justification and evidence relating to the laboratory incident and OOS result conclusively or inconclusively demonstrates causative laboratory error. o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation. o For all laboratory incident and OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements. A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include but not be limited to addressing the following: o Quality unit oversight of laboratory investigations o Identification of adverse laboratory control trends o Resolution of causes of laboratory variation o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified o Adequately scoping of each investigation and its CAPA o Revised OOS investigation procedures with these and other remediations For more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production at https://www.fda.gov/media/158416/download. A possible laboratory error is insufficient to close an investigation at Phase 1. Whenever an investigation lacks conclusive evidence of laboratory error, a thorough investigation of potential manufacturing causes must be performed. 2. Failure to ensure that all specifications, sampling plans, test procedures are scientifically sound and appropriate to ensure that your raw materials, intermediate and API, conform to established standards of quality and purity. Your firm tests your raw materials, starting materials, and finished APIs using methods developed in-house. However, your firm failed to validate (or verify if compendial testing is used) multiple test methods that you use. In your response, you commit to validating and/or verifying your test methods. You provided an example of a newly completed method validation for a starting material used in the production of (b)(4) API. However, the validation report lacks adequate data to demonstrate that the method is appropriately validated for its intended use, including insufficient robustness, precision, suitability, and other testing parameter studies. Test methods must be validated to show they are suitable for their intended use or verified to show at least equivalence with United States Pharmacopeia (USP) compendial methods. In response to this letter, provide: A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system. The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing. A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your suppliers’ Certificates of Analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers’ results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program. CGMP Consultant We acknowledge that you engaged a consultant to evaluate your operations and to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. Conclusion The deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations. If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff may also allow you to meet obligations you may have to report permanent discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(a). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any deviations. Failure to address any deviations may also result in the FDA refusing admission of articles manufactured at Cdymax (India) Pharma Private Limited, at 77d & 116/117, KIADB Industrial Area, Jigani, Bangalore, Karnataka, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B). This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days.1 Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3009882550 and ATTN: Bryce Hammer. Sincerely, /S/ Francis Godwin Director Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research ___________________

Shoplet - 717846 - 11/13/2025

WARNING LETTER November 13, 2025 RE: 717846 Tony Ellison: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://www.shoplet.com/. The FDA has observed that your website offers the following triclosan-containing consumer and health care antiseptic nonprescription drug products: “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 800 mL,” “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1 Gallon,” and “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1000 mL” (hereinafter Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan) for sale in the United States. Based on our review, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below. Unapproved New Drug and Misbranded Drug Violations “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Examples from the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” product labeling, including your website, https://www.shoplet.com, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following: “…Anti-Microbial... Kills bacteria on contact..” [from your https://www.shoplet.com/Ameriderm-AmeriWash-Antimicrobial-Lotion-Soap-with-Triclosan-1-Gallon/ADM210EA/spdv product page] Based on the above labeling evidence, “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are intended for use as triclosan-containing consumer and health care antiseptic nonprescription drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless it is lawfully marketed under section 505G of the FD&C Act. No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug products identified above. With respect to triclosan-containing consumer and health care antiseptic nonprescription drug products, such as the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan,” such products are subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, these products fall under section 505G(a)(5) of the FD&C Act, 21 U.S.C. 355h(a)(5), because FDA has determined that topical consumer and health care antiseptic nonprescription drug products containing triclosan are not GRASE under a final determination issued under 21 CFR part 330.1 Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved applications pursuant to section 505 of the FD&C Act are in effect for these drug products. Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). In addition, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355. The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Conclusion The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov, please include your firm name and the unique identifier “717846” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration ________________

Save Rite Medical - 717838 - 11/13/2025

WARNING LETTER November 13, 2025 RE: 717838 Save Rite Medical: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.saveritemedical.com. The FDA has observed that your website offers the following triclosan-containing consumer and health care antiseptic nonprescription drug products: “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 800 mL” and “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1000 mL” (hereinafter “Ameriderm Ameriwash Antimicrobial Lotion Soaps with Triclosan”) for sale in United States. Based on our review, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below. Unapproved New Drug and Misbranded Drug Violations “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Examples from the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” product labeling, including your website, www.saveritemedical.com, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following: “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” “Antimicrobial…soap with Triclosan…made especially for the healthcare industry…for use in hospitals and nursing homes. •Kills bacteria on contact….” [from your website https://www.saveritemedical.com/products/ameriwash-antimicrobial-lotion-soap-with-triclosan-1000-ml] Based on the above labeling evidence, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are intended for use as triclosan-containing consumer and health care antiseptic nonprescription drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug products identified above. With respect to triclosan-containing consumer and health care antiseptic nonprescription drug products, such as the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan,” such products are subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, these products fall under section 505G(a)(5) of the FD&C Act, 21 U.S.C. 355h(a)(5), because FDA has determined that topical consumer and health care antiseptic nonprescription drug products formulated with triclosan as an active ingredient are not GRASE under a final determination issued under 21 CFR part 330.1 Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved application pursuant to section 505 of the FD&C Act is in effect for these drug products. Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). In addition, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355. The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Conclusion The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov, please include your firm name and the unique identifier “717838” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration _________________

Medical Mega - 717840 - 11/13/2025

WARNING LETTER November 13, 2025 RE: 717840 Medical Mega: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://www.medicalmega.com. The FDA has observed that your website offers the following triclosan-containing consumer and health care antiseptic nonprescription drug products: “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 800 mL,” “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1 Gallon,” and “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1000 mL” (hereinafter “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan”) for sale in United States. Based on our review, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below. Unapproved New Drug and Misbranded Drug Violations “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Examples from the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” product labeling, including your website, https://www.medicalmega.com, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following: “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” “Anti-microbial…Kills bacteria on contact…” [from your https://medicalmega.com/AmeriWash-Antimicrobial-Lotion-Soap-with-Triclosan-1000-mL product page] Based on the above labeling evidence, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are intended for use as triclosan-containing consumer and health care antiseptic nonprescription drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug products identified above. With respect to triclosan-containing consumer and health care antiseptic nonprescription drug products, such as the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan,” such products are subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, these products fall under section 505G(a)(5) of the FD&C Act, 21 U.S.C. 355h(a)(5), because FDA has determined that topical consumer and health care antiseptic nonprescription drug products formulated with triclosan as an active ingredient are not GRASE under a final determination issued under 21 CFR part 330.1 Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved application pursuant to section 505 of the FD&C Act is in effect for these drug products. Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). In addition, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355. The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Conclusion The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov, please include your firm name and the unique identifier “717840” in the subject line of the email. Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration _________________

Verdure Sciences, Inc. - 717259 - 11/10/2025

WARNING LETTER FDA Ref. No.: 25-HFD-45-11-01 Dear Mr. Patel: This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between June 25 and July 12, 2024. The investigators representing FDA reviewed the role of Verdure Sciences, Inc. (Verdure) as the sponsor of a clinical investigation (Protocol 005, “Randomized, Double-Blind Evaluation of Maple leaf extract (Maplifa for Photoaging”) of the investigational drug Maplifa® (1% or 5%). This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected. At the conclusion of the inspection, the FDA investigators presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your July 24, 2024, written response to the Form FDA 483. From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your July 24, 2024, written response, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312), governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following: You failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with an investigational new drug that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)]. FDA regulations require a sponsor to submit, and to have in effect, an IND before initiating a clinical investigation of a drug that is subject to 21 CFR 312.2(a) [see 21 CFR 312.20(a) and (b) and 312.40(a)] in human subjects, unless the clinical investigation qualifies for an IND exemption under 21 CFR 312.2. Verdure failed to comply with these requirements. Specifically, Verdure initiated Protocol 005, a clinical investigation of the investigational drug Maplifa®, which is subject to section 505 of the FD&C Act [21 U.S.C. 355], without submitting and having in effect an IND. In Verdure’s July 24, 2024, written response to the Form FDA 483, you stated that Verdure did not believe an IND was required because Protocol 005 assessed the use of topical Maplifa® skin regimen on the cosmetic appearance of skin photoaging (wrinkles and skin brightness). You further stated that the study ingredient was not being studied for use to affect the structure or function of the body or to prevent, treat, mitigate, cure, or diagnose a disease because Protocol 005’s primary endpoint was to detect change in skin brightness as measured by a skin colorimeter and facial photographic image analysis, which are widely used to study the efficacy of cosmetic formulations. Furthermore, you stated that the study met all the IND exemption requirements as listed in an FDA proposed rule1 that proposed exemptions for certain clinical investigations of products lawfully marketed as a food or cosmetic when the product is to be studied to evaluate its use as a drug. Finally, you stated that Verdure signed a Clinical Study Agreement (CSA) with a third-party vendor to conduct Protocol 005, and the CSA transferred the obligation of the “sponsor” to this third party. We address your arguments below. 1. Protocol 005 was a clinical investigation of a drug subject to 21 CFR 312. Section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] defines drug, in part, as “articles (other than food) intended to affect the structure or any function of the body of man or other animals….” Whether an investigational article is a drug depends on the intended use of the article in the investigation. Based on Protocol 005 and the final study report, the investiga-tional product, Maplifa®, as used in this clinical investigation, was a drug as defined in section 201(g)(1) of the FD&C Act because Maplifa® was studied for use in the mitigation or treatment of facial wrinkles, skin brightness, skin redness, erythema, and hyperpigmentation. Specifically, as described in the protocol, the objective of Protocol 005 was to “examine the effects of topical Maplifa® on facial wrinkles, redness, and pigmentation.” The final study report for Protocol 005 also stated that “Maplifa® is a proprietary, standardized, phenolic-enriched A[cer] rubrum extract formula that is intended to whiten skin and reduce wrinkle production, primarily due to its anti-oxidative and anti-glycating properties.” The final study report further stated, “To further understand the influence of applying topical A. rubrum-based products to the skin, we conducted a randomized, double-blind evaluation to explore the influence of [glucitol-core containing gallotannins] on reduction of face redness, hyperpigmen-tation, and wrinkle formation.” According to the protocol and the final study report, to assess the efficacy of Maplifa®, Protocol 005’s outcome measures included changes in skin brightness, pigmentation, erythema, redness, and wrinkles. These outcomes were measured using different methods, including skin colorimeter, image-based analysis, and in-person clinical assessments. Therefore, Protocol 005 collected study data to assess the effect of Maplifa® on the skin, as measured by methods including skin colorimeter and facial photographic image analysis. Considering the nature of the study, as described above, we conclude that the evidence collected during the inspection shows that Maplifa® was intended to affect the structure or function of the body; it was not merely intended to affect cosmetic appearance. Maplifa® was therefore intended for use as a drug for the clinical investigation conducted under Protocol 005. As a result, you were required to submit an IND before conducting the clinical investigation. 2. The clinical investigation conducted under Protocol 005 does not meet the exemption criteria in 21 CFR 312.2(b)(1) and is subject to the IND requirements under 21 CFR 312. FDA regulations require a sponsor to submit an IND before conducting a clinical investigation of a drug in human subjects, unless the clinical investigation qualifies for an IND exemption under 21 CFR 312.2(b). Under 21 CFR 312.2(b)(1), the clinical investigation of a lawfully marketed drug product in the United States is exempt from the IND regulations for a clinical investigation if all the exemption criteria in 21 CFR 312.2(b) are met. Protocol 005 does not qualify for any of the exemptions listed at 21 CFR 312.2 from the application of 21 CFR 312. To be IND-exempt under 21 CFR 312.2, the investigational product must be lawfully marketed in the United States as a drug product. Verdure’s July 24, 2024, written response claims that Maplifa® is marketed only as a cosmetic ingredient, not as a drug product. However, as described above, the intended use of Maplifa® under Protocol 005 was as a drug, and we are not aware of any basis to conclude that it is a lawfully marketed drug. You also argue that Maplifa® is exempt from the IND requirements based on an FDA proposed rule. However, your response provided no reasoning to support this assertion. A proposed rule, until final, is not binding and does not supersede or otherwise change existing FDA regulations regarding IND exemptions. Your response also did not explain why Protocol 005 would have qualified for an exemption, even if the proposed rule were final and in effect. Moreover, we note that study participants received the study drug and the study was completed before FDA proposed the regulation at issue for public comment. As explained above, the study materials for Protocol 005 establish that Maplifa®’s intended use in the clinical trial was that of a drug. Further, Protocol 005 was not exempt from 21 CFR 312, and Verdure was required to submit an IND before initiating a clinical investigation of a drug in human subjects. 3. Verdure is the sponsor of the clinical investigation conducted under Protocol 005 as defined in 21 CFR 312.3. FDA regulations define a sponsor as a person who takes responsibility for and initiates a clinical investigation [see 21 CFR 312.3]. Under 21 CFR 312.52, a sponsor may transfer responsibility for any or all of its obligations to a Contract Research Organization (CRO) and must describe any such transfer, including the specific obligations transferred, in writing; however, if all obligations are transferred, a general statement that all obligations have been transferred is acceptable. Both the CSA and the work order collected during the inspection and provided in your written response identify Verdure Sciences, Inc., as the “Sponsor” and the third-party vendor as the “Service Provider.” Neither of these documents describes which of Verdure’s sponsor obligations for conducting this study, if any, were transferred to the third-party vendor. Additionally, the CSA and work order do not contain any general statements that sponsor obligations have been transferred. Your written response refers to a provision of the CSA, which states that the third-party vendor “will conduct the Study according to the provisions of the Protocol and this Agreement and in conformance with all [Applicable Laws].” This provision does not describe, in either general or specific terms, any obligations that transferred from you to the third-party vendor. In your written response, you stated that as a corrective and preventive action, Verdure will ensure that all third parties, such as a CRO, comply with all applicable FDA regulations, including filing for an IND, unless exempt. However, your written response is inadequate because it does not provide sufficient details of a corrective and preventive action plan for developing and implementing procedures that comply with IND regulations, should Verdure decide in the future to initiate another clinical investigation for which an IND is required. Without this information, we are unable to determine whether Verdure will comply with IND regulations in the future. As a sponsor, you are responsible for complying with IND requirements, including submitting and having in effect an IND before initiating a clinical investigation, and it is Verdure’s responsibility, as a sponsor, to be aware of and to follow all applicable FDA regulations. Verdure’s failure to submit, and to have in effect, an IND before initiating Protocol 005 with an investigational drug raises significant concerns about the safety and welfare of enrolled subjects, and raises concerns about the validity and integrity of the data collected during the conduct of this clinical investigation. This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations. This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration. Should you have any questions or concerns about this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov. Your written response and any pertinent documentation should be addressed to: Brittany L. Garr, MPH Branch Chief Compliance Enforcement Branch Division of Enforcement and Postmarketing Safety Office of Scientific Investigations Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration Building 51, Room 5352 10903 New Hampshire Avenue Silver Spring, MD 20993 Sincerely yours, /S/ David C. Burrow, Pharm.D., J.D. Director Office of Scientific Investigations Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration ____________________

FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

Español Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature. “Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.” Menopause is a normal, natural change in a woman’s life when her period stops, usually occurring between ages 45 and 55. Menopause is often referred to as “the change of life” or “the change.” During menopause a woman’s body slowly produces less of the hormones estrogen and progesterone. A woman has reached menopause when she has not had a menstrual period for 12 consecutive months. Hot flashes occur in around 80% of menopausal women and can include periods of sweating, flushing and chills lasting for several minutes. Some women who experience hot flashes and have a history of vaginal bleeding, stroke, heart attack, blood clots or liver disease, cannot take hormone therapies. Veozah is not a hormone. It targets the neural activity which causes hot flashes during menopause. Patients taking Veozah should take one 45 milligram pill orally, once a day, with or without food. The pill should be taken at the same time each day. If a dose is missed, or not taken at the regular time, patients should take it as soon as possible and return to their regular schedule the following day. The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase 3 clinical trials. In both trials, after the first 12 weeks, the women on placebo were then re-randomized to Veozah for a 40-week extension study to evaluate safety. Each trial ran a total of 52 weeks. The average age of the trial participants was 54 years old. The prescribing information for Veozah includes a warning for elevated hepatic transaminase, or liver injury. Before using Veozah, patients should have blood work done to test for liver damage. While on Veozah, routine bloodwork should be performed every three months for the first nine months of using the medication. Patients experiencing symptoms related to liver damage—such as nausea, vomiting, or yellowing of the skin and eyes—should contact a physician. Veozah cannot be used with CYP1A2 inhibitors. Patients with known cirrhosis, severe renal damage or end-stage renal disease should not take Veozah. The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases. The FDA granted the Veozah application Priority Review designation. The approval of Veozah was granted to Astellas Pharma US, Inc. Related Information ###

FDA approves epcoritamab-bysp for follicular lymphoma indications

On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024). Full prescribing information for Epkinly will be posted on Drugs@FDA. Approval of epcoritamab-bysp with lenalidomide and rituximab (R2) was based on EPCORE FL-1 (Study M20-638; NCT05409066), a randomized, open-label trial that enrolled 488 patients with relapsed or refractory FL. Patients were randomized (1:1) to receive epcoritamab-bysp plus R2 or R2 alone. Patients had a median of 1 prior line of systemic therapy (range: 1 to 7); 24% and17% had two and three or more prior lines, respectively. Efficacy was established based on progression free survival (PFS) and overall response rate (ORR) as assessed by an independent review committee (IRC) using Lugano 2014 Criteria. The study demonstrated superiority of PFS and ORR in the epcoritamab-bysp arm. The PFS hazard ratio was 0.21 (95% CI: 0.13, 0.33; p-value <0.0001). The median PFS was not reached (NR) (95% CI: 21.9 months, NR) in the epcoritamab-bysp arm and was 11.2 months (95% CI: 10.5, NR) in the control arm. The ORR was 89% (95% CI: 84, 93) in the epcoritamab-bysp arm and 74% (95% CI: 68, 79) in the control arm. The prescribing information includes boxed warnings for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), as well as warnings and precautions for infections and cytopenias. Serious adverse reactions occurred in 51% of the patients in the epcoritamab-bysp arm, including serious infections in 28%. CRS occurred in 24% of patients, including serious CRS in 12%. ICANS occurred in 0.8%. The recommended regimen for epcoritamab-bysp in combination with R2 consists of epcoritamab-bysp administered subcutaneously for up to twelve 28-day cycles, with lenalidomide on Days 1-21 of each cycle and rituximab for 5 cycles. The recommended epcoritamab-bysp dosage is a 3 step-up dosage schedule in Cycle 1 (0.16 mg on Day 1, 0.8 mg on Day 8, 3 mg on Day 15, and 48 mg on Day 22), followed by weekly dosing of 48 mg in Cycle 2 and 3, then every 4-week dosing of 48 mg in Cycles 4 to 12. This review was conducted as a Summary Review and used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted breakthrough designation, priority review, and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

FDA approves epcoritamab-bysp for follicular lymphoma indicationsOn November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024). 11/18/2025FDA approves new interchangeable biosimilar to PerjetaOn November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta.11/13/2025FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutationOn November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.11/13/2025FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myelomaOn November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).11/6/2025FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutationOn October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.10/24/2025FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myelomaOn October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.10/23/2025FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinomaOn October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.10/8/2025FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancerOn October 2, 2025, the Food and Drug Administration approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.) in combination with atezolizumab (Tecentriq, Genentech Inc.) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech Inc.) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.10/2/2025FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancerOn September 25, 2025, the Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.9/25/2025FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injectionOn September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck). See the prescribing information for the specific indications.9/19/2025FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromasOn September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.9/10/2025FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancerOn September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.9/9/2025FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutationsOn August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.8/8/2025FDA grants accelerated approval to dordaviprone for diffuse midline gliomaOn August 6, 2025, the Food and Drug Administration granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals, Inc.), a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.8/6/2025FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutationsOn July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.7/2/2025FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myelomaOn July 2, 2025, the Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.7/2/2025FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancerOn June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.6/23/2025FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphomaOn June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL). 6/18/2025FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinomaOn June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent.6/12/2025FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancerOn June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).6/12/2025FDA approves taletrectinib for ROS1-positive non-small cell lung cancerOn June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).6/11/2025FDA approves darolutamide for metastatic castration-sensitive prostate cancerOn June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.6/3/2025FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canalOn May 15, 2025, the Food and Drug Administration approved retifanlimab-dlwr (Zynyz, Incyte Corporation) with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also approved retifanlimab-dlwr, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.5/15/2025FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.5/14/2025FDA approves belzutifan for pheochromocytoma or paragangliomaOn May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This represents the first FDA approval of an oral therapy for PPGL.5/14/2025FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancerOn May 8, 2025, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.5/8/2025FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinomaOn April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).4/23/2025FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinomaOn April 11, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).4/11/2025FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancerOn April 8, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan.4/08/2025FDA approves durvalumab for muscle invasive bladder cancerOn March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).3/28/2025FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indicationOn March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.3/28/2025FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET). 3/26/2025FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)On March 19, 2025, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1).3/19/2025FDA approves vimseltinib for symptomatic tenosynovial giant cell tumorOn February 14, 2025, the Food and Drug Administration approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.2/14/2025FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphomaOn February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.2/12/2025FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resectionOn February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.2/11/2025FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDSOn January 21, 2025, the Food and Drug Administration approved treosulfan (Grafapex, medac GmbH), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).2/06/2025FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancerOn January 27, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.1/27/2025Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatmentThe U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and discuss testing options for DPD deficiency with their patients. 1/24/2025FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancerOn January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.1/17/2025FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancerOn January 16, 2025, the Food and Drug Administration approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. 1/16/2025FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphomaOn January 16, 2025, the Food and Drug Administration granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).1/16/2025FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injectionOn December 27, 2024, the Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb Company) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo, Bristol Myers Squibb Company) indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.12/27/2024FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutationOn December 20, 2024, the Food and Drug Administration granted accelerated approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.12/20/2024FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patientsOn December 18, 2024, the Food and Drug Administration approved remestemcel-L-rknd (Ryoncil, Mesoblast, Inc.), an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients 2 months of age and older. Ryoncil is the first FDA-approved MSC therapy.12/18/2024FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancerOn December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.12/18/2024FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinomaOn December 13, 2024, the Food and Drug Administration approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. 12/13/2024FDA approves durvalumab for limited-stage small cell lung cancerOn December 4, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.12/4/2024FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma On December 4, 2024, the Food and Drug Administration granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for adults with the following: advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy. 12/4/2024FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract cancerOn November 20, 2024, the Food and Drug Administration granted accelerated approval to zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc.), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.11/21/2024FDA approves updated drug labeling for fludarabine phosphate under Project RenewalOn November 19, 2024, the Food and Drug Administration approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.11/19/2024FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocationOn November 15, 2024, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.11/15/2024FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemiaOn November 8, 2024, the Food and Drug Administration approved obecabtagene autoleucel (Aucatzyl, Autolus Inc.), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).11/8/2024FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukemiaOn October 29, 2024, the Food and Drug Administration granted accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).10/29/2024FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma On October 18, 2024, the Food and Drug Administration approved zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.10/18/2024FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancerOn October 10, 2024, the Food and Drug Administration approved inavolisib (Itovebi, Genentech, Inc.) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.10/10/2024FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancerOn October 3, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. 10/3/2024FDA approves selpercatinib for medullary thyroid cancer with a RET mutationOn September 27, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.9/27/2024FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapyOn September 25, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.9/25/2024FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myelomaOn September 20, 2024, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).9/20/2024FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutationsOn September 19, 2024, the Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.9/19/2024FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesotheliomaOn September 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM).9/17/2024FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancerOn September 17, 2024, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and letrozole co-pack (Kisqali Femara Co-Pack, Novartis Pharmaceuticals Corporation) for the same indication.9/17/2024FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injectionOn September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). See the prescribing information for the specific indications. 9/12/2024FDA approves lazertinib with amivantamab-vmjw for non-small lung cancerOn August 19, 2024, the Food and Drug Administration approved lazertinib (Lazcluze, Janssen Biotech, Inc.) in combination with amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. 8/19/2024FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancerOn August 15, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.8/15/2024FDA approves axatilimab-csfr for chronic graft-versus-host diseaseOn August 14, 2024, the Food and Drug Administration approved axatilimab-csfr (Niktimvo, Incyte Corporation), a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.8/14/2024FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutationOn August 6, 2024, the Food and Drug Administration approved vorasidenib (Voranigo, Servier Pharmaceuticals LLC), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection.8/6/2024FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcomaOn August 2, 2024, the Food and Drug Administration granted accelerated approval to afamitresgene autoleucel (TECELRA, Adaptimmune, LLC), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.8/2/2024FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapyOn August 1, 2024, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients with primary advanced or recurrent endometrial cancer (EC). 8/1/2024FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myelomaOn July 30, 2024, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research & Development, LLC) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).7/30/2024FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphomaOn June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 6/26/2024FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancerOn June 21, 2024, the Food and Drug Administration granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics, Inc.) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.6/21/2024FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinomaOn June 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.6/17/2024FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemiaOn June 14, 2024, the Food and Drug Administration approved blinatumomab (Blincyto, Amgen Inc.) for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy.6/14/2024FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancerOn June 14, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).6/14/2024FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumorsOn June 13, 2024, the Food and Drug Administration granted accelerated approval to repotrectinib (AUGTYRO, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.6/13/2024FDA approves selpercatinib for RET fusion-positive thyroid cancerOn June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 6/12/2024FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemiaOn June 6, 2024, the Food and Drug Administration approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs).6/6/2024FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphomaOn May 30, 2024, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi).5/30/2024FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumorsOn May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older.5/29/2024FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancerOn May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.5/16/2024FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphomaOn May 15, 2024, the Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.5/15/2024FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancerOn April 29, 2024, the Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication.4/29/2024FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade gliomaOn April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.4/23/2024FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETSOn April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Lutetium Lu 177 dotatate received approval for this indication for adults in 2018.4/23/2024FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancerOn April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.4/22/2024FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancerOn April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.4/18/2024FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumorsOn April 5, 2024, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.4/5/2024FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancerOn March 22, 2024, the Food and Drug Administration approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. [now a part of AbbVie]) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Patients are selected based on an FDA-approved test.3/22/2024FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection productsOn March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence (OCE).3/21/2024FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemiaOn March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).3/19/2024FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphomaOn March 7, 2024, the Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa, BeiGene USA, Inc.) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.3/7/2024FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinomaOn March 6, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).3/7/2024FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemiaOn March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).3/6/2024FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indicationsOn March 1, 2024, the Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.3/1/2024FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancerOn February 16, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.2/16/2024FDA grants accelerated approval to lifileucel for unresectable or metastatic melanomaOn February 16, 2024, the Food and Drug Administration granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.), a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.2/16/2024FDA approves tepotinib for metastatic non-small cell lung cancerOn February 15, 2024, the Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. 2/15/2024FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinomaOn February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.2/13/2024FDA approves erdafitinib for locally advanced or metastatic urothelial carcinomaOn January 19, 2024, the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy.1/18/2024FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancerOn January 12, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.1/12/2024FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancerOn December 15, 2023, the Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy.12/15/2023FDA approves belzutifan for advanced renal cell carcinomaOn December 14, 2023, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).12/14/2023FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastomaOn December 13, 2023, the Food and Drug Administration approved eflornithine (IWILFIN, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.12/13/2023FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphomaOn December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.12/1/2023FDA approves nirogacestat for desmoid tumorsOn November 27, 2023, the Food and Drug Administration approved nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors.11/27/2023FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrenceOn November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).11/17/2023FDA approves capivasertib with fulvestrant for breast cancerOn November 16, 2023, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.11/16/2023FDA approves pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinomaOn November 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.11/16/2023FDA approves repotrectinib for ROS1-positive non-small cell lung cancerOn November 15, 2023, the Food and Drug Administration approved repotrectinib (Augtyro, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).11/15/2023FDA approves fruquintinib in refractory metastatic colorectal cancerOn November 8, 2023, the Food and Drug Administration approved fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) for adult patients with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.11/8/2023FDA amends pembrolizumab’s gastric cancer indicationOn November 7, 2023, the Food and Drug Administration revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test.11/7/2023FDA approves pembrolizumab with chemotherapy for biliary tract cancerOn October 31, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC).10/31/2023FDA approves toripalimab-tpzi for nasopharyngeal carcinomaOn October 27, 2023, the Food and Drug Administration approved toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.10/27/2023FDA approves ivosidenib for myelodysplastic syndromesOn October 24, 2023, the Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.10/24/2023FDA expands pediatric indication for entrectinib and approves new pellet formulationOn October 20, 2023, the Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted accelerated approval to entrectinib for pediatric patients 12 years of age and older for this indication.10/20/2023FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancerOn October 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).10/16/2023FDA approves nivolumab for adjuvant treatment of Stage IIB/C melanomaOn October 13, 2023, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older.10/13/2023FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutationOn October 11, 2023, the Food and Drug Administration approved encorafenib (Braftovi, Array BioPharma Inc., a wholly owned subsidiary of Pfizer) with binimetinib (Mektovi, Array BioPharma Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.10/11/2023FDA approves bosutinib for pediatric patients with chronic myelogenous leukemia On September 26, 2023, the Food and Drug Administration approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed (ND) or resistant or intolerant (R/I) to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 mg and 100 mg.9/26/2023FDA approves new and updated indications for temozolomide under Project RenewalOn September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda).9/14/2023FDA approves melphalan as a liver-directed treatment for uveal melanomaOn August 14, 2023, the Food and Drug Administration approved HEPZATO KIT (melphalan for Injection/Hepatic Delivery System) containing melphalan (HEPZATO, Delcath Systems, Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.8/14/2023FDA grants accelerated approval to elranatamab-bcmm for multiple myelomaOn August 14, 2023, the Food and Drug Administration granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. 8/14/2023FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancerOn August 11, 2023, the Food and Drug Administration approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test. 8/11/2023FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myelomaOn August 9, 2023, the Food and Drug Administration granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.8/9/2023FDA approves pralsetinib for non-small cell lung cancer with RET gene fusionsOn August 9, 2023, the Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.8/9/2023FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancerOn August 2, 2023, the Food and Drug Administration approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. FDA had previously approved single-agent LONSURF for this indication in September 2015.8/2/2023FDA approves dostarlimab-gxly with chemotherapy for endometrial cancerOn July 31, 2023, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).7/31/2023FDA approves quizartinib for newly diagnosed acute myeloid leukemiaOn July 20, 2023, the Food and Drug Administration approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test.7/20/2023FDA approves talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancerOn June 20, 2023, the Food and Drug Administration approved talazoparib (Talzenna, Pfizer, Inc.) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).6/20/2023FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomasOn June 15, 2023, the Food and Drug Administration granted accelerated approval to glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.6/16/2023FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancerOn May 31, 2023, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.5/31/2023FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphomaOn May 19, 2023, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.5/19/2023FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphomaOn April 19, 2023, the Food and Drug Administration approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.) with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater.4/19/2023FDA approves omidubicel to reduce time to neutrophil recovery and infection in patients with hematologic malignanciesOn April 17, 2023, the Food and Drug Administration approved omidubicel-onlv (Omisirge, Gamida Cell Ltd.) for use in adult and pediatric patients (12 years and older) with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.4/17/2023FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinomaOn April 3, 2023, the Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.4/3/2023FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinomaOn March 22, 2023, the Food and Drug Administration granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte Corporation) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).3/22/2023FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutationOn March 16, 2023, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills.3/16/2023FDA expands early breast cancer indication for abemaciclib with endocrine therapyOn March 3, 2023, the Food and Drug Administration (FDA) approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.3/3/2023FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancerOn February 9, 2023, the Food and Drug Administration (FDA) approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.2/9/2023FDA approves sacituzumab govitecan-hziy for HR-positive breast cancerOn February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.2/3/2023FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancerOn January 27, 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. 1/27/2023FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphomaOn January 27, 2023, the Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. 1/27/2023FDA approves pembrolizumab as adjuvant treatment for non-small cell lung cancerOn January 26, 2023, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).1/26/2023FDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphomaOn January 19, 2023, the Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa, BeiGene USA, Inc.) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1/19/2023FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancerOn January 19, 2023, the Food and Drug Administration (FDA) granted accelerated approval to tucatinib (Tukysa, Seagen Inc.) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.1/19/2023FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphomaOn December 22, 2022, the Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 12/23/2022FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancerOn December 16, 2022, the Food and Drug Administration approved nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals) for adult patients with high-risk Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.12/16/2022FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project RenewalOn December 14, 2022, the Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. 12/14/2022FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLCOn December 12, 2022, the Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C¬-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.12/12/2022FDA grants approval to atezolizumab for alveolar soft part sarcomaOn December 9, 2022, the Food and Drug Administration (FDA) approved atezolizumab (Tecentriq, Genentech, Inc.) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).12/9/2022FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutationOn December 1, 2022, the Food and Drug Administration (FDA) approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.12/1/2022FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant)On November 18, 2022, the Food and Drug Administration approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals). Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. It also is approved to be administered every 48 hours at a dose of 25 mg/m2 intramuscularly.11/18/2022FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancerOn November 14, 2022, the Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc.) for adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx is a folate receptor alpha directed antibody and microtubule inhibitor conjugate. Patients are selected for therapy based on an FDA-approved test.11/14/2022FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancerOn November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.11/10/2022FDA approves brentuximab vedotin in combination with chemotherapy for pediatric patients with classical Hodgkin lymphomaOn November 10, 2022, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen, Inc.) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL). This is the first pediatric approval for brentuximab vedotin.11/10/2022FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancerOn November 8, 2022, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.11/8/2022FDA approves teclistamab-cqyv for relapsed or refractory multiple myelomaOn October 25, 2022, the Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.10/25/2022FDA approves tremelimumab in combination with durvalumab for unresectable hepatocellular carcinomaOn October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC).10/21/2022FDA grants accelerated approval to futibatinib for cholangiocarcinomaOn September 30, 2022, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho Oncology, Inc.) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.9/30/2022FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancerOn September 21, 2022, the Food and Drug Administration granted regular approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.9/21/2022FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumorsOn September 21, 2022, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.9/21/2022FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumorsOn September 20, 2022, the Food and Drug Administration approved sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors.9/20/2022FDA approves durvalumab for locally advanced or metastatic biliary tract cancerOn September 2, 2022, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer (BTC).9/02/2022FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangementOn August 26, 2022, the Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.8/26/2022FDA approves ibrutinib for pediatric patients with chronic graft versus host disease, including a new oral suspensionOn August 24, 2022, the Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.8/24/2022FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancerOn August 11, 2022, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-mutant NSCLC.8/11/2022FDA approves capmatinib for metastatic non-small cell lung cancerOn August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib (Tabrecta, Novartis Pharmaceuticals Corp.) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.8/10/2022FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancerOn August 5, 2022, the Food and Drug Administration approved darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).8/5/2022FDA approves fam-trastuzumab deruxtecan-nxki for HER2-low breast cancerOn August 5, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.8/5/2022FDA approves crizotinib for ALK-positive inflammatory myofibroblastic tumorOn July 14, 2022, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).7/14/2022FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphomaOn June 24, 2022, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. It is not indicated for the treatment of patients with primary central nervous system lymphoma.6/24/2022FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutationOn June 22, 2022, the Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.6/22/2022FDA approves tisagenlecleucel for relapsed or refractory follicular lymphomaOn May 27, 2022, the Food and Drug Administration granted accelerated approval to tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.5/27/2022FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications On May 27, 2022, the Food and Drug Administration approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC): nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-based chemotherapy nivolumab in combination with ipilimumab (Yervoy, Bristol-Myers Squibb Company) 5/27/2022FDA approves ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemiaOn May 25, 2022, the Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) in combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.5/25/2022FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemiaOn May 20, 2022, the Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).5/20/2022FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancerOn May 4, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy.5/4/2022 FDA approves alpelisib for PIK3CA-related overgrowth spectrum On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.4/6/2022 FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma On April 1, 2022, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma.4/1/2022FDA approves Pluvicto for metastatic castration-resistant prostate cancerOn March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., a Novartis company) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. 3/23/2022FDA approves pembrolizumab for advanced endometrial carcinomaOn March 21, 2022, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck), as a single agent, for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.3/21/2022FDA approves Opdualag for unresectable or metastatic melanomaOn March 18, 2022, the Food and Drug Administration approved nivolumab and relatlimab-rmbw (Opdualag, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab3/18/2022FDA approves olaparib for adjuvant treatment of high-risk early breast cancerOn March 11, 2022, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib3/11/2022FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancerOn March 4, 2022, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting.3/4/2022FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myelomaOn February 28, 2022, the Food and Drug Administration approved ciltacabtagene autoleucel (CARVYKTI, Janssen Biotech, Inc.) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.2/28/2022FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanomaOn January 25, 2022, the Food and Drug Administration approved tebentafusp-tebn (Kimmtrak, Immunocore Limited), a bispecific gp100 peptide-HLA-directed CD3 T cell engager, for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. 1/25/2022FDA approves abatacept for prophylaxis of acute graft versus host disease On December 15, 2021, the Food and Drug Administration approved abatacept (Orencia, Bristol-Myers Squibb Company) for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. 12/15/2021FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma On December 3,2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection.12/3/2021FDA approves rituximab plus chemotherapy for pediatric cancer indicationsOn December 2, 2021, the Food and Drug Administration approved rituximab (Rituxan, Genentech, Inc.) in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL).12/2/2021FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma On November 30, 2021, the Food and Drug Administration approved daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) and carfilzomib (Kyprolis, Amgen, Inc.) plus dexamethasone foradult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. 12/01/2021FDA approves pafolacianine for identifying malignant ovarian cancer lesionsOn November 29, 2021, the Food and Drug Administration approved pafolacianine (Cytalux, On Target Laboratories, LLC), an optical imaging agent, for adult patients with ovarian cancer as an adjunct for interoperative identification of malignant lesions. Pafolacianine is a fluorescent drug that targets folate receptor which may be overexpressed in ovarian cancer. It is used with a Near-Infrared (NIR) fluorescence imaging system cleared by the FDA for specific use with pafolacianine.11/29/2021FDA approves sirolimus protein-bound particles for malignant perivascular epithelioid cell tumorOn November 22, 2021, the Food and Drug Administration approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro, Aadi Bioscience, Inc.) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).11/23/2021FDA approves pembrolizumab for adjuvant treatment of renal cell carcinomaOn November 17, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.11/17/2021FDA approves asciminib for Philadelphia chromosome-positive chronic myeloid leukemiaOn October 29, 2021, the Food and Drug Administration granted accelerated approval to asciminib (Scemblix, Novartis AG) for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), and approved asciminib for adult patients with Ph+ CML in CP with the T315I mutation.10/29/2021FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancerOn October 15, 2021, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.10/15/2021 FDA approves pembrolizumab combination for the first-line treatment of cervical cancerOn October 13, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.10/13/2021FDA approves abemaciclib with endocrine therapy for early breast cancer On October 12, 2021, the Food and Drug Administration approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test. This is the first CDK 4/6 inhibitor approved for adjuvant treatment of breast cancer.10/12/2021FDA recognizes Memorial Sloan-Kettering database of molecular tumor marker informationOn October 7, 2021, the Food and Drug Administration granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.10/7/2021FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemiaOn October 1, 2021, the Food and Drug Administration approved brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).10/1/2021FDA approves ruxolitinib for chronic graft-versus-host diseaseOn September 22, 2021, the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte Corp.) for chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.9/22/2021FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancerOn September 20, 2021, the Food and Drug Administration granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.9/20/2021FDA approves cabozantinib for differentiated thyroid cancerOn September 17, 2021, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine.9/17/2021FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutationsFood and Drug Administration granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals, Inc.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.9/15/2021FDA grants accelerated approval to zanubrutinib for marginal zone lymphomaFood and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.9/14/2021FDA approves zanubrutinib for Waldenström’s macroglobulinemiaFood and Drug Administration approved zanubrutinib (Brukinsa, BeiGene) for adult patients with Waldenström’s macroglobulinemia (WM).8/31/2021FDA approves ivosidenib for advanced or metastatic cholangiocarcinomaFood and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.8/25/2021FDA approves nivolumab for adjuvant treatment of urothelial carcinomaFood and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection.8/19/2021FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. 8/18/2021FDA approves belzutifan for cancers associated with von Hippel-Lindau diseaseFood and Drug Administration approved belzutifan (Welireg, Merck), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery8/13/2021FDA approves lenvatinib plus pembrolizumab for advanced renal cell carcinomaFood and Drug Administration approved the combination of lenvatinib (Lenvima, Eisai) plus pembrolizumab (Keytruda, Merck) for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).8/10/2021FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancerFood and Drug Administration approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.7/26/2021 FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.7/21/2021FDA approves belumosudil for chronic graft-versus-host diseaseFood and Drug Administration approved belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.7/16/2021FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myelomaFood and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.7/9/2021FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer Food and Drug Administration approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. 7/9/2021FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphomaFood and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze, Jazz Pharmaceuticals, Inc.) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase..7/1/2021FDA approves avapritinib for advanced systemic mastocytosis Food and Drug Administration approved avapritinib (Ayvakit™, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). 6/16/2021FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinomaFood and Drug Administration granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test5/28/2021FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLCFood and Drug Administration granted accelerated approval to sotorasib (Lumakras™, Amgen, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.5/28/2021FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancerFDA granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) for adult patients

FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies

Proposed removal of risk statements about cardiovascular diseases, breast cancer, and probable dementia from the Boxed Warnings, as well as other proposed safety-related labeling changes, to clarify the benefit/risk considerations for these drugs [11/10/2025] Today, the U.S. Food and Drug Administration (FDA) informed application holders of menopausal hormone therapies (MHT), also commonly referred to as Hormone Replacement Therapy (HRT), about requested labeling changes aimed to better clarify the benefit/risk considerations for these medications. MHTs are used to provide relief from common menopause symptoms, such as hot flashes and night sweats (also known as vasomotor symptoms (VMS)) and symptoms due to changes to the vagina, vulva, and urinary tract caused by decreased estrogen, also known as vulvovaginal atrophy (VVA), or now more commonly known as genitourinary syndrome of menopause (GSM). Some MHTs are also approved to prevent osteoporosis (bone weakening). The proposed labeling changes follow the agency’s comprehensive assessment of relevant literature since the publication of two long-term, large-scaled studies under the Women’s Health Initiative (WHI), updated drug utilization review, and public input about MHTs. The two WHI studies investigated the role of estrogen plus progestin (WHI EP) in women with a uterus or estrogen alone (WHI E) in women without a uterus in preventing heart disease, cancer, and bone fractures in postmenopausal women 50 to 79 years. Both WHI studies began in the 1990s and were prematurely stopped in the early 2000s (WHI EP in 2002 and WHI E in 2004) because investigators reported an increased risk of breast cancer in the WHI EP study, and an increased risk of stroke and lack of evidence of coronary artery disease prevention in the WHI E study after an average of five and seven years of follow-up, respectively. Two other WHI studies evaluating estrogen plus progestin or estrogen alone in women 65 to 79 years for dementia prevention also reported an increased risk of probable dementia. Based on the WHI findings, in 2003, FDA began approving class-wide labeling changes for estrogen plus progestogen and estrogen-alone products approved for VMS, VVA, and prevention of postmenopausal osteoporosis. These changes would eventually include a Boxed Warning for increased risk of serious adverse events, including cardiovascular disorders, invasive breast cancer, and probable dementia. In the ensuing years, the agency received questions about whether the Boxed Warnings resulting from the WHI findings were warranted, particularly for local vaginal estrogen-only products. Certain groups have raised concerns about the applicability of the WHI studies’ methodologies and interpretations to menopausal women for whom MHT is warranted. The women’s health community has also raised concerns that a substantial proportion of symptomatic menopausal/postmenopausal women for whom MHT is indicated and would be beneficial are not prescribed MHT or decline treatment with MHT because of these Boxed Warnings. Most recently, FDA held an Expert Panel on July 17, 2025, and the panel focused on the risks and benefits of MHT. After the Expert Panel meeting, FDA requested broad public input on the risks and benefits related to menopause hormone therapy. Although menopause is a natural process in a woman’s reproductive life, menopausal symptoms can significantly and adversely impact women’s quality of life. FDA has approved numerous MHTs to treat moderate/severe hot flashes, VVA, and for some, prevention of bone thinning. In 2020, the U.S. Census Bureau data reported approximately 41 million women in the U.S. were aged 45 to 64 years, the ages when VMS is most common.[1] A study published in 2021 found the prevalence of moderate to severe VMS in women 45 to 65 years to be approximately 34%.[2] However, FDA’s review of drug utilization data from U.S. outpatient prescriptions for MHT indicated that, in 2020, approximately 2 million women aged 46 to 65 years received a prescription for systemic estrogen-alone or combined estrogen plus progestogen. Such drug use data suggest MHT may be under-utilized among women likely to benefit from MHT. FDA recognizes the primary aim of the WHI trials was to evaluate the impact of hormone therapy on cardiovascular disease and other chronic medical conditions in post-menopausal women across all ages, with the average participant aged 63 years. In contrast, women typically experience bothersome VMS much earlier in the menopausal transition time (average age ranging between 45-55 years). The average age of women experiencing menopause in the U.S. is 51 years, meaning that the age-related health conditions in the WHI population did not match the typically younger and healthier women who may start MHT for bothersome VMS. To help address this incongruity and better inform patients and prescribers about the level of risks associated with MHT in the younger cohort of women (age range 45-55 years) most likely to start these drugs for VMS, FDA considered multiple additional analyses and long-term follow-up of the WHI participants since the initial WHI results. Regarding the probable dementia risk, the WHI studies enrolled women aged 65 to 79 years, a population much older than women starting MHT. Based on the agency’s assessment of available data and recognition that menopause symptoms can significantly impact a woman’s quality of life, FDA has re-considered the benefit/risk balance of these drugs and is requesting the following key changes to the prescribing information of MHT products: For all MHTs (systemic and local vaginal products): Specifically in the label’s Boxed Warning, the agency’s most prominent safety-related warning: Remove the language related to cardiovascular diseases, breast cancer, and probable dementia Remove language related to endometrial cancer except in the systemic estrogen-alone drugs Remove the recommendation to use the lowest effective dose for the shortest amount of time In the labeling as a whole: Remove the probable dementia warning In addition to the above changes: For systemic products: In the labeling as a whole: Add consideration of starting hormone therapy for moderate to severe VMS in women < 60 years old or < 10 years since menopause Add WHI data in women 50-59 years old Retain the Boxed Warning about endometrial cancer in the systemic estrogen-alone products Retain information about cardiovascular diseases and breast cancer warnings For local vaginal estrogen products: In the labeling as a whole: Condense safety information and prioritize information most relevant to the local vaginal formulation Bibliography References:

Novel Drug Approvals for 2025

37.Redemploplozasiran11/18/2025To reduce triglycerides in adults with familial chylomicronemia syndrome36.Komziftiziftomenib11/13/2025To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options35.Kygevvidoxecitine and doxribtimine11/3/2025To treat thymidine kinase 2 deficiency in patients who start to show symptoms when they are 12 years old or younger34.Lynkuetelinzanetant10/24/2025To treat moderate-to-severe vasomotor symptoms due to menopause33.Jascaydnerandomilast10/7/2025To treat idiopathic pulmonary fibrosis32.Rhapsidoremibrutinib9/30/2025To treat chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment31.Palsonifypaltusotine9/25/2025To treat acromegaly in adults who had an inadequate response to surgery and/or for whom surgery is not an option30.Inluriyoimlunestrant9/25/2025To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy29.Forzinity elamipretide9/19/2025To improve muscle strength in patients with Barth syndrome weighing at least 30 kg28.Keytruda Qlex pembrolizumab and berahyaluronidase alfa-pmph 9/19/2025To treat adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab 27.Wayrilzrilzabrutinib8/29/2025To treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids26.Dawnzeradonidalorsen8/21/2025To prevent attacks of hereditary angioedema25.Brinsupribrensocatib8/12/2025To treat non-cystic fibrosis bronchiectasis24.Hernexeoszongertinib8/8/2025To treat adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy23.Modeysodordaviprone8/6/2025To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy22.Vizzaceclidine7/31/2025To treat presbyopia21.Sephiencesepiapterin7/28/2025To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet20.Anzupgodelgocitinib7/23/2025To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response19.Ekterlysebetralstat7/3/2025To treat acute attacks of hereditary angioedema Drug Trials Snapshot18.Zegfrovysunvozertinib7/2/2025To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with disease progression on or after platinum-based chemotherapy17.Lynozyficlinvoseltamab-gcpt7/2/2025To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibody16.Andembrygaradacimab-gxii6/16/2025To prevent attacks of hereditary angioedema Drug Trials Snapshot15.Ibtrozitaletrectinib6/11/2025To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer Drug Trials Snapshot14.Enflonsia clesrovimab-cfor6/9/2025To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season Drug Trials Snapshot13.Tryptyracoltremon5/28/2025To treat the signs and symptoms of dry eye disease Drug Trials Snapshot12.Emrelistelisotuzumab vedotin-tllv5/14/2025To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy Drug Trials Snapshot11.Avmapki Fakzynja Co-Pack avutometinib and defactinib5/8/2025To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy Drug Trials Snapshot10.Imaavynipocalimab-aahu4/29/2025To treat generalized myasthenia gravis Drug Trials Snapshot9.penpulimab-kcqxpenpulimab-kcqx4/23/2025In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy Drug Trials Snapshot8.Vanrafiaatrasentan4/02/2025To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression Drug Trials Snapshot7.Qfitliafitusiran3/28/2025To prevent or reduce the frequency of bleeding episodes in hemophilia A or B Press Release Drug Trials Snapshot6.Blujepagepotidacin3/25/2025To treat uncomplicated urinary tract infections Drug Trials Snapshot5.Romvimzavimseltinib2/14/2025To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity Drug Trials Snapshot4.Gomeklimirdametinib2/11/2025To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection Drug Trials Snapshot3.Journavxsuzetrigine1/30/2025To treat moderate to severe acute pain Press Release Drug Trials Snapshot

Advisory Letters

Search Advisory Letters (Table results update automatically as you type) The uses related to these products are not necessarily being promoted by the manufacturers of the products. An asterisk (*) under the table column "Status” indicates that this firm has cooperated with FDA by removing claims for serious diseases from the products listed on this webpage. This compliance status concerns only claims about the cure, prevention, treatment, or mitigation of the serious disease listed on this webpage and in no way indicates whether or not the listed products otherwise comply with the laws and regulations enforced by FDA.

FDA approves drug to reduce triglycerides in adults with familial chylomicronemia syndrome

Action Today, the U.S. Food and Drug Administration (FDA) approved Redemplo (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Disease or Condition FCS is a rare genetic disorder that affects the body's ability to break down fats (triglycerides (TGs)) in the bloodstream. This leads to abnormally high levels of chylomicrons, which are particles that carry triglycerides. Normal TG levels are less than 150 mg/dL; levels above 500 mg/dL are considered severely high (severe hypertriglyceridemia). People with FCS can have TG levels in the thousands. These high TG levels can cause severe abdominal pain, inflammation of the pancreas (acute pancreatitis), and fatty deposits in the skin (xanthomas). Some of these symptoms, specifically acute pancreatitis, can be life-threatening. For those with FCS, symptoms can develop in infancy, but some patients may not experience symptoms until they are adults. FCS has an estimated prevalence of 1 to 10 per 1,000,000 people. Effectiveness The efficacy of Redemplo was demonstrated in a randomized, placebo-controlled, double-blind trial (NCT05089084) in adults with genetically confirmed or clinically diagnosed FCS maintained on a low-fat diet (≤20 grams fat per day). Patients were randomly assigned to receive four total doses of Redemplo 25 mg or matching placebo, injected subcutaneously (under the skin) once every three months over a 12-month treatment period. The primary endpoint was percent change in fasting TGs from baseline to month 10. The median percent change in TG from baseline to month 10 in the Redemplo treatment group was -59% compared to the placebo group. Redemplo is administered as a 25 mg injection once every three months into the front of the thigh or abdomen. The outer area of the upper arm can be used as an injection site if a health care provider or caregiver administers the injection. Safety Information The most common side effects are hyperglycemia (high blood sugar), headache, nausea, and injection site reaction. Designations Redemplo received Fast Track, Breakthrough Therapy, and Orphan Drug designations for this indication.