NDA News-CliniExpert

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

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