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 Approves Zanvastro (zilganersen) to Treat Alexander Disease
September 03, 2026 -- The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients. Zanvastro is the first FDA-approved treatment for Alexander disease... -
FDA Approves PharmaEssentia’s BESREMi (ropeginterferon alfa-2b-njft) for Adults with Essential Thrombocythemia
BURLINGTON, Mass.--(BUSINESS WIRE)--August 31, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446) today announced the U.S. Food and Drug Administration (FDA) has approved BESREMi® (ropeginterferon... -
FDA Approves Mimrylo (rusfertide) for the Treatment of Polycythemia Vera
OSAKA, Japan and CAMBRIDGE, Massachusetts, August 28, 2026 – Takeda (TSE:4502/NYSE:TAK) announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for Mimrylo (rusfertide) for the treatment of erythrocytosis... -
FDA Approves Bixlenvo (bictegravir and lenacapavir) for the Treatment of HIV in Adults Who Are Virologically Suppressed
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR)... -
FDA Approves Stelara for Pediatric Ulcerative Colitis
August 28, 2026 -- The U.S. Food and Drug Administration has approved Stelara (ustekinumab) injection for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years old and older. On April 15, 2026... -
FDA Approves Lilly's Mounjaro (tirzepatide) to Reduce Cardiovascular Risk in Adults with Type 2 Diabetes
INDIANAPOLIS, August 28, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Mounjaro (tirzepatide), a dual GIP and GLP-1 hormone receptor agonist, to lower the risk of... -
Moderna Receives U.S. FDA Approval for Updated 2026-2027 Spikevax and mNEXSPIKE COVID-19 Vaccines
CAMBRIDGE, MA / ACCESS Newswire / August 27, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2026-2027 formulas for... -
Pfizer and BioNTech Receive U.S. FDA Approval for XFG-Adapted Comirnaty COVID-19 Vaccine
NEW YORK & MAINZ, Germany--(BUSINESS WIRE) August 27, 2026 -- Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the U.S. Food and Drug Administration (FDA) has approved...