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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

FDA Approves Lasix ONYU (furosemide) for Treatment of Edema in Heart Failure

Burlington, Massachusetts, October 8, 2025 – SQ Innovation, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its drug-device combination Lasix ONYU (furosemide inject

FDA Approves Eydenzelt (aflibercept-boav), a Biosimilar to Eylea

INCHEON, South Korea, Oct. 9, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Eydenzelt (aflibercept-boav), biosimilar referencing Ey

FDA Approves Rhapsido (remibrutinib) for the Treatment of Chronic Spontaneous Urticaria

EAST HANOVER, N.J., Sept. 30, 2025 -- Novartis announced today that Rhapsido (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic

FDA Approves Enoby (denosumab-qbde), a Biosimilar to Prolia

Budapest, Hungary and London, UK, 29 September 2025 -- Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) an

FDA Approves Xtrenbo (denosumab- qbde), a Biosimilar to Xgeva