2025 Biological License Application Supplement Noteworthy Approvals

CARVYKTI ciltacabtagene autoleucel To include results from a protocol-specified second interim analysis from CARTITUDE-4. The supplement revises the Boxed Warning, Section 5 (Warnings and Precautions), Section 6 (Adverse Reactions), and the Medication Guide to include the risk of immune effector cell-associated enterocolitis, T cell lymphoma of the gastrointestinal tract, and gastrointestinal perforation. Additionally, the supplement revises Section 14 (Clinical Studies) of the USPI to include a protocol-specified analysis for overall survival from CARTITUDE-4.125746/249 Janssen Biotech, Inc. 920 US Highway 202, P.O. Box 300 Raritan, NJ 08869 Lic. # 1864 10/10/2025Whole Blood and Blood Components (Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived)Treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment.125396/21 Stanford Blood Center 3373 Hillview Avenue Palo Alto, CA 94304 10/10/2025VYJUVEK beremagene geperpavec-svdtExpand the indication to treat wounds in adults and pediatric patients (0 to 16 years of age) with dystrophic epidermolysis bullosa, and to allow application of VYJUVEK in home setting by a healthcare professional, patient or caregiver.125774/89Krystal Biotech, Inc. 2100 Wharton Street Suite 701 Pittsburgh, PA 15203 Lic. # 23019/12/2025VONVENDI von Willebrand Factor (Recombinant)To expand the current approved adult prophylaxis indication for type 3 von Willebrand disease (VWD) to include adults with type 1 and type 2 VWD and to expand the use to pediatric patients with VWD for on demand treatment and control of bleeding episodes and perioperative management of bleeding.125577/691Takeda Pharmaceuticals USA, Inc 500 Kendall Street Cambridge, MA 02142 Lic. # 18989/5/2025NUVAXOVID COVID-19 Vaccine, AdjuvantedTo include the 2025-2026 Formula and associated labeling revisions.125817/6Novavax, Inc. 700 Quince Orchard Road Gaithersburg, MD 20878 Lic. # 23498/27/2025MNEXSPIKE COVID-19 Vaccine, mRNATo include the 2025-2026 Formula and associated labeling revisions for use in individuals who are 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.125835/6ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 22568/27/2025SPIKEVAX COVID-19 Vaccine, mRNATo include the 2025-2026 Formula and associated labeling revisions.125752/305Moderna TX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 22568/27/2025COMIRNATY COVID-19 Vaccine, mRNA To include: 10 mcg drug product (2025-2026 Formula) in the single-dose vial presentation manufactured at the Pfizer, Puurs facility and associated labeling revisions, for use in individuals 5 years through 11 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19; and 30 mcg drug product (2025-2026 Formula) in the single-dose prefilled syringe presentation manufactured at the Pfizer, Puurs facility and associated labeling revisions, for use in individuals who are 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. 125742/656 BioNTech Manufacturing GmbH Pfizer, Inc. 66 Hudson Boulevard East New York, NY 10001 Lic. # 2229 8/27/2025AREXVY Respiratory Syncytial Virus Vaccine, AdjuvantedTo include data on the safety and efficacy of AREXVY against Respiratory Syncytial Virus (RSV) associated lower respiratory tract disease in individuals 60 years of age and older over three RSV seasons following administration of a single dose.125775/297GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7464 Lic. # 16178/8/2025CAPVAXIVE Pneumococcal 21-valent Conjugate VaccineTo update Section 8 "Use in Specific Populations", Section 6 “Clinical Trials Experience”, and Section 14 “Clinical Studies” of the package insert for the inclusion of individuals living with HIV (V116-007) and individuals at increased risk of pneumococcal disease (V116-008).125814/149Merck Sharp & Dohme LLC P.O. Box 1000 UG2D-68 North Wales, PA 19454-2505 Lic. # 00027/31/2025Imovax Rabies Rabies VaccineTo update the package insert to include a 2-dose pre-exposure prophylaxis dosing regimen in addition to the currently approved 3-dose regimen.103931/5342Sanofi Pasteur SA Discovery Drive Swiftwater, PA 18370-0187 Lic. # 17247/24/2025SPIKEVAX COVID-19 VaccineTo prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals who are 65 years of age and older, or 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and to include a new 0.25 mL pre-filled syringe presentation.125752/276 ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 7/9/2025 GAMMAGARD LIQUID ERC Immune globulin infusion (human) 10% solution For the indication of a replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.125105/2184 Takeda Pharmaceuticals U.S.A., Inc. 650 E. Kendall Street Cambridge, MA 02142 Lic. # 1898 6/27/2025 MRESVIA Respiratory Syncytial Virus Vaccine To revise the indication and usage to include active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.125796/37 ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 6/12/2025 ABRYSVO Respiratory Syncytial Virus Vaccine To update the Package Insert to include safety and efficacy data from two full Respiratory Syncytial Virus (RSV) seasons from the Phase 3 clinical study C3671013, and the final safety data from the Phase 3 study C3671008.125769/277 Pfizer Inc. 500 Arcola Road Collegeville, PA 19426 Lic. # 2001 6/9/2025MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine To update the Package Insert to include safety and effectiveness data from postmarketing requirement (PMR) studies MET41, MET42 and MET61 that support lowering the age for use to include individuals 6 weeks through 23 months of age. 125701/262 Sanofi Pasteur, Inc. Discovery Drive Swiftwater, PA 18370-0187 Lic. # 1725 5/23/2025AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted To update the Package Insert to include data from two clinical studies of concomitant administration of AREXVY with influenza vaccines in individuals 65 years of age and older.125775/247 GlaxoSmithKline Biologicals 14200 Shady Grove Road Rockville, MD 20850-7464 Lic. # 1617 5/23/2025Jivi Antihemophilic Factor (recombinant), PEGylated-auclTo revise the indication to include pediatric patients 7 to <12 years of age.125661/972 Bayer HealthCare LLC 100 Bayer Boulevard, P.O. Box 915 Whippany, NJ 07981-0915 Lic. # 0008 5/14/2025FluBlok Influenza VaccineTo update the product labeling to include data and results from PREA PMR studies VAP00026 (3-8 year olds) and VAP00027 (9-17 and 18-49 year olds), and to use data from VAP00027 to support extending the Flublok indication to individuals 9 through 17 years of age, and to fulfill (PREA) PMR #1 and (PREA) PMR #2 (125285/471).125285/613Protein Sciences Corporation Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370 Lic. #179503/31/2025