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 Lipfendra (enlicitide) Oral PCSK9 Inhibitor to Reduce LDL-C in Adults with Hypercholesterolemia
RAHWAY, N.J.--(BUSINESS WIRE) July 16, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide) tablets 20 mg as an adjunct to... -
FDA Approves Revtorpyk (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer
MINNEAPOLIS, July 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced that the U.S. Food and Drug... -
FDA Approves Leqembi Iqlik (lecanemab-irmb) Subcutaneous Injection as an Initiation Dose for Early Alzheimer’s Disease
TOKYO and CAMBRIDGE, Mass., July 13, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a... -
FDA Approves Sarclisa Escena (isatuximab-irfc) Subcutaneous Injection for the Treatment of Multiple Myeloma
Paris, July 10, 2026. The US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all... -
U.S. FDA Approves Padcev plus Keytruda or Keytruda Qlex as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility
NEW YORK & TOKYO--(BUSINESS WIRE) July 10, 2026 -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has... -
FDA Approves Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder Cancer
RAHWAY, N.J.--(BUSINESS WIRE) July 10, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) and Keytruda Qlex... -
FDA Approves Ennumo (pegfilgrastim-pccg), a Biosimilar to Neulasta
RALEIGH, N.C., July 9, 2026 /PRNewswire/ — Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today that the... -
Octapharma USA Announces Expanded FDA Approval of Wilate for von Willebrand Disease Prophylaxis in Children Younger Than 6 Years
PARAMUS, N.J., July 8, 2026 /PRNewswire/ -- On July 2, 2026, the U.S. Food and Drug Administration (FDA) approved the use of wilate® (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) for routine prophylaxis to reduce the frequency...