Novel Drug Approvals for 2025

39.Voyxactsibeprenlimab-szsi11/25/2025To reduce proteinuria in primary immunoglobulin A nephropathy in adults at risk for disease progression38.Hyrnuosevabertinib11/19/2025To treat locally advanced or metastatic non-squamous non-small cell lung cancer with tumors that have activating HER2 tyrosine kinase domain activating mutations in patients who received a systemic therapy37.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 bronchiectasis Drug Trials Snapshot24.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 therapy Drug Trials Snapshot22.Vizzaceclidine7/31/2025To treat presbyopia21.Sephiencesepiapterin7/28/2025To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet Drug Trials Snapshot20.Anzupgodelgocitinib7/23/2025To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response Drug Trials Snapshot19.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 Snapshot