FDA Approves Cardamyst (etripamil) Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia
MONTREAL and CHARLOTTE, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced that the U.S. Food and Drug Administration (FDA) approved its first commer
FDA Approves Lerochol (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol
CINCINNATI, Ohio – December 15, 2025 -- LIB Therapeutics Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, tod
FDA Approves Nuzolvence (zoliflodacin) for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents
WALTHAM, Mass. -- (BUSINESS WIRE) -- Dec. 12, 2025 -- Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), today announced that the U.S. Food and Drug Administration (FDA) h
FDA Approves Waskyra (etuvetidigene autotemcel) Gene Therapy for the Treatment of Wiskott-Aldrich Syndrome
December 10, 2025 -- Fondazione Telethon announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Waskyra, an ex vivo gene therapy for
FDA Approves Avance (acellular nerve allograft–arwx) for Nerve Discontinuities
ALACHUA, Fla. and TAMPA, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical technologies for the restoration of periph
FDA Approves Armlupeg (pegfilgrastim-unne), a Biosimilar to Neulasta
Mumbai, India and Naples, FL -- December 1, 2025: Global pharma major Lupin Limited (Lupin), today announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg™ (pegf
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
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