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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

FDA Approves Ferabright (ferumoxytol injection) Contrast Agent for Magnetic Resonance Imaging of the Brain

Woburn, MA — October 17, 2025 -- Azurity Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Ferabright (ferumoxytol injection), the first and only iron

FDA Approves Jascayd (nerandomilast) to Treat Idiopathic Pulmonary Fibrosis

October 9, 2025 -- Boehringer Ingelheim’s Jascayd (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) as an oral treatment option for idiopathic pulmonary fibrosis