FDA Grants Accelerated Approval for Voyxact (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression
November 26, 2025 -- Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) today announce the U.S. Food and Drug Administration (FDA) has
FDA Approves Itvisma (onasemnogene abeparvovec-brve) Gene Replacement Therapy for Adults and Children Two Years and Older with Spinal Muscular Atrophy
EAST HANOVER, N.J., Nov. 24, 2025 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of chil
FDA Approves Osvyrti (denosumab-desu), a Biosimilar to Prolia
RALEIGH, N.C., Nov. 20, 2025 /PRNewswire/ -- Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies,
FDA Approves Jubereq (denosumab-desu), a Biosimilar to Xgeva
RALEIGH, N.C., Nov. 20, 2025 /PRNewswire/ -- Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies,
FDA Grants Accelerated Approval to Hyrnuo (sevabertinib) for Non-Squamous Non-Small Cell Lung Cancer
On November 19, 2025 -- the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advan
FDA Approves Redemplo (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome
PASADENA, Calif.–(BUSINESS WIRE)–Nov. 18, 2025 -- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has approved Redemplo (plozasiran), a
FDA Approves Komzifti (ziftomenib) for the Treatment of Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
SAN DIEGO and TOYKO, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced the U.S. Food and Drug Administration (FDA) has granted
FDA Approves Kygevvi (doxecitine and doxribtimine) for the Treatment of Thymidine Kinase 2 Deficiency
ATLANTA, GA, November 3, 2025 -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that Kygevvi has been granted approval by the U.S. Food and Drug Administration (FDA)
FDA Approves Lynkuet (elinzanetant) for Moderate to Severe Hot Flashes Due to Menopause
WHIPPANY, N.J., October 24, 2025 -- Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Lynkuet® (elinzanetant) 60mg capsules, the first and only dual neurokinin (NK) target
FDA Approves Javadin (clonidine hydrochloride) Oral Solution for the Treatment of Hypertension
Woburn, MA - October 24, 2025 -- Azurity Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Javadin (clonidine hydrochloride) oral solution, the only F
FDA Approves Contepo (fosfomycin) for Injection for the Treatment of Complicated Urinary Tract Infections
October 22, 2025 -- The U.S. Food and Drug Administration (FDA) has approved Contepo (fosfomycin) for injection for the treatment of patients 18 years of age and older with complicated urinary tract i
FDA Approves Epioxa (riboflavin 5’-phosphate) Ophthalmic Solution for the Treatment of Keratoconus
Aliso Viejo, CA – October 20, 2025 -- Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal di
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