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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Tryngolza (olezarsen) Approved to Reduce Triglycerides and the Risk of Acute Pancreatitis in Patients with Severe Hypertriglyceridemia
CARLSBAD, Calif.--(BUSINESS WIRE)--Jun. 24, 2026-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides (TG) and... -
FDA Approves Rextovy (naloxone hydrochloride) Nasal Spray for Over-the-Counter Use
June 16, 2026 -- The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose... -
FDA Approves Utebzi (tebipenem pivoxil) for Adults with Complicated Urinary Tract Infections
June 17 2026 -- GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs)... -
Sanofi’s Tzield Approved in the US as the First Disease-Modifying Therapy for Patients Recently Diagnosed with Stage 3 Type 1 Diabetes
Paris, June 13, 2026. The US Food and Drug Administration (FDA) has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with... -
FDA Approves Lilly's Ebglyss (lebrikizumab-lbkz) for One Maintenance Dose Every Eight Weeks in Patients with Moderate-to-Severe Atopic Dermatitis
INDIANAPOLIS, June 9, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of Ebglyss... -
U.S. FDA Approves Pfizer’s Hympavzi for the Treatment of Two Additional Hemophilia A or B Patient Populations with Significant Medical Need
NEW YORK--(BUSINESS WIRE) June 08, 2026 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Hympavzi (marstacimab-hncq) to include the treatment of patients with... -
FDA Approves Xocova (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure
OSAKA, Japan, June 1, 2026 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved Xocova... -
FDA Approves Zaynich (cefepime and zidebactam) for the Treatment of Complicated Urinary Tract Infections
MUMBAI & SHORT HILLS, NEW JERSEY May 30, 2026 – Wockhardt today announced that the U.S. Food and Drug Administration (FDA) has approved Zaynich (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with...