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 Hibsago (bepirovirsen) for the Treatment of Chronic Hepatitis B
London, UK -- 20 October 2026 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with... -
Cosette Pharmaceuticals Announces FDA Approval of Evoxac (cevimeline HCl) Oral Solution
BRIDGEWATER, N.J.--(BUSINESS WIRE) October 20, 2026 --Cosette Pharmaceuticals, Inc. (“Cosette”), a U.S.-based specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Evoxac... -
Jemperli (dostarlimab-gxly) Approved in US as First and Only Immunotherapy for Adults with MSI-H/dMMR Locally Advanced Rectal Cancer
Philadelphia, PA -- October 19 2026 -- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) as the first and only immunotherapy for adults with stage II and III microsatellite... -
FDA Approves Genentech’s Enspryng, a First-in-Class IL-6R Inhibitor, as the First and Only At-Home Subcutaneous Treatment Option for Thyroid Eye Disease (TED)
South San Francisco, CA -- October 15, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Enspryng® (satralizumab-mwge) for the treatment of... -
UCB Announces U.S. FDA Approval for Zilbrysq (zilucoplan) Autoinjector Self-administration for Adults Living with Generalized Myasthenia Gravis
Brussels, Belgium and Atlanta, Georgia – October 16, 2026 – UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the first self-administered... -
FDA Approves Brytly (apraclonidine) Ophthalmic Solution for Relief of Eye Redness
GENEVA--(BUSINESS WIRE) October 16, 2026 -- Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced that the U.S. Food and Drug Administration (FDA) has approved Brytly Redness Reliever Eye... -
Viatris Receives U.S. FDA Approval for Ryzumvi for the Treatment of Presbyopia
PITTSBURGH, Oct. 16, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Ryzumvi (phentolamine ophthalmic solution 0.75%) for the treatment of... -
FDA Expands Anktiva Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease
CULVER CITY, Calif., October 14, 2026 — ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for Anktiva (nogapendekin...