Drugs.com - New Drug Approvals
New drug approvals news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
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FDA Grants Accelerated Approval for Genglycos (pariglasgene brecaparvovec-opnr) Gene Therapy for the Treatment of Glycogen Storage Disease Type Ia
NOVATO, Calif., August 19, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Genglycos™ (pariglasgene brecaparvovec-opnr)... -
FDA Approves Pasatru (garetosmab-grts) for the Treatment of Fibrodysplasia Ossificans Progressiva
TARRYTOWN, N.Y., August 19, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted approval for Pasatru™ (garetosmab-grts) to reduce formation of new... -
U.S. Food and Drug Administration Approves an Autoinjector Version of Lerochol (lerodalcibep-liga) and Updated Indication
CINCINNATI--(BUSINESS WIRE)--LIB Therapeutics, Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced the U.S. Food and Drug Administration (FDA)... -
FDA Approves Tauklarify (florquinitau F 18 injection), an F18-Labeled Tau PET Imaging Agent for Alzheimer’s Disease
BEDFORD, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and... -
FDA Grants Accelerated Approval to Zenbexus (iberdomide) in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone for the Treatment of Multiple Myeloma
PRINCETON, N.J.--(BUSINESS WIRE)--August 13, 2026 Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and... -
FDA Grants Accelerated Approval to Tudriqev (vusolimogene oderparepvec-wtpg) in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma
WOBURN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration... -
FDA Approves mFLUSIVA (influenza vaccine, mRNA) for the Prevention of Seasonal Influenza
CAMBRIDGE, MA / ACCESS Newswire / August 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA® (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults... -
FDA Approves Mucinex 12HR Cold & Fever Multi-Symptom (dextromethorphan, guaifenesin and naproxen) for Cold & Flu Symptoms
NUTLEY, N.J., AUGUST 5, 2026 – Reckitt announced today a milestone for the cold and flu category and the company: Mucinex® 12HR Cold & Fever Multi-Symptom is the first U.S. Food and Drug Administration (FDA)-approved over-the-counter...