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Drugs.com - New Drug Approvals
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Last updated about 2 hours ago
FDA Approves Lerochol (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol
about 9 hours ago
CINCINNATI, Ohio – December 15, 2025 – LIB Therapeutics Inc. (LIB), a...
Enhertu Plus Pertuzumab Approved in the US as First New Treatment in a Decade for the First-Line Treatment of Patients with HER2-Positive Metastatic Breast Cancer
1 day ago
December 15, 2025 -- AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) in...
FDA Approves Nuzolvence (zoliflodacin) for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents
3 days ago
WALTHAM, Mass.--(BUSINESS WIRE)--Dec. 12, 2025-- Innoviva Specialty Therapeutics, a subsidiary of Innoviva...
FDA Approves Akeega as the First Precision Therapy for BRCA2-Mutated Metastatic Castration-Sensitive Prostate Cancer
3 days ago
HORSHAM, PA, December 12, 2025/PRNewswire/ – Johnson & Johnson (NYSE:JNJ) announced today...
FDA Approves Cardamyst (etripamil) Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia
3 days ago
MONTREAL and CHARLOTTE, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals...
Acadia Pharmaceuticals Announces FDA Approval of Daybue Stix (trofinetide) for Oral Solution, a New Powder Formulation of Trofinetide for the Treatment of Rett Syndrome
3 days ago
SAN DIEGO—(BUSINESS WIRE)—Dec. 12, 2025—Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that...
BioCryst Announces FDA Approval of Orladeyo (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to <12 Years
3 days ago
RESEARCH TRIANGLE PARK, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals...
Blujepa (gepotidacin) Approved by US FDA as Oral Option for Treatment of Uncomplicated Urogenital Gonorrhoea (uGC)
4 days ago
London, UK December 11, 2025 -- GSK plc (LSE/NYSE: GSK) today announced...
Blujepa (gepotidacin) Approved by US FDA as Oral Option for Treatment of Uncomplicated Urogenital Gonorrhea (uGC)
4 days ago
London, UK December 11, 2025 -- GSK plc (LSE/NYSE: GSK) today announced...
FDA Approves Uplizna for Adults With Generalized Myasthenia Gravis
5 days ago
THOUSAND OAKS, Calif., Dec. 11, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced...
FDA Approves Waskyra (etuvetidigene autotemcel) Gene Therapy for the Treatment of Wiskott-Aldrich Syndrome
5 days ago
December 10, 2025 -- Fondazione Telethon announced today that the U.S. Food...
Bristol Myers Squibb’s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)
8 days ago
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the...