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Drugs.com - New Drug Approvals
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Last updated 2 days ago
U.S. FDA Grants Accelerated Approval to Bayer’s Hyrnuo (sevabertinib) as a First-Line Targeted Therapy for Patients with HER2-Mutated Non-Small Cell Lung Cancer
3 days ago
WHIPPANY, N.J., September 9, 2026 – Bayer announced today that following Priority...
U.S. FDA Grants Accelerated Approval to Bayer’s Targeted Therapy Sevabertinib as a First-Line Treatment Option for Adults with HER2-Mutant Non-Small Cell Lung Cancer
3 days ago
Berlin, September 9, 2026 – Following Priority Review and Breakthrough Therapy Designation...
FDA Grants Accelerated Approval to Etcamah (camizestrant) in Combination with a CDK4/6 Inhibitor for the Treatment of Advanced HR-Positive Breast Cancer
8 days ago
September 4, 2026 -- AstraZeneca’s Etcamah (camizestrant) in combination with a cyclin-dependent...
FDA Approves Zanvastro (zilganersen) for the Treatment of Alexander Disease
9 days ago
CARLSBAD, Calif.--(BUSINESS WIRE)--September 3, 2026-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced...
FDA Approves Zanvastro (zilganersen) to Treat Alexander Disease
9 days ago
September 03, 2026 -- The U.S. Food and Drug Administration has approved...
FDA Approves Stelara for Pediatric Ulcerative Colitis
15 days ago
August 28, 2026 -- The U.S. Food and Drug Administration has approved...
FDA Approves PharmaEssentia’s BESREMi (ropeginterferon alfa-2b-njft) for Adults with Essential Thrombocythemia
12 days ago
BURLINGTON, Mass.--(BUSINESS WIRE)--August 31, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia...
FDA Approves Zimrixby (rituximab-cdxx), a Biosimilar to Rituxan
about 1 month ago
Fresenius Kabi, an operating company of Fresenius, announced today that the U.S...
FDA Approves Lilly's Mounjaro (tirzepatide) to Reduce Cardiovascular Risk in Adults with Type 2 Diabetes
16 days ago
INDIANAPOLIS, August 28, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)...
FDA Approves Bixlenvo (bictegravir and lenacapavir) for the Treatment of HIV in Adults Who Are Virologically Suppressed
15 days ago
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that...
Pfizer and BioNTech Receive U.S. FDA Approval for XFG-Adapted Comirnaty COVID-19 Vaccine
16 days ago
NEW YORK & MAINZ, Germany--(BUSINESS WIRE) August 27, 2026 -- Pfizer Inc...
Moderna Receives U.S. FDA Approval for Updated 2026-2027 Spikevax and mNEXSPIKE COVID-19 Vaccines
16 days ago
CAMBRIDGE, MA / ACCESS Newswire / August 27, 2026 / Moderna, Inc...