FDA Approves Jideytro (zidesamtinib) for Previously Treated ROS1-Positive Non-Small Cell Lung Cancer
London, UK July 22, 2026 -- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adu
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 Lipfend
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,
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 p
FDA Grants Accelerated Approval for Trutakna (atacicept-vymj) for Adult Patients with Primary IgA Nephropathy
BRISBANE, Calif., July 07, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) h
FDA Approves Tregzi (Orca-T) as First and Only Precision-Engineered Cell Therapy for Allogeneic Transplant in Adults with Hematological Malignancies
MENLO PARK, CA, June 30, 2026 -- Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the U.S. Food a
FDA Approves Lumvoa (veligrotug-vvze) for the Treatment of Thyroid Eye Disease
WALTHAM, Mass.–(BUSINESS WIRE) -- June 26, 2026 -- Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class
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 o
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 Administr
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 anti
FDA Approves Decnupaz (pivekimab sunirine-pvzy) for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
NORTH CHICAGO, Ill., May 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Decnupaz (pivekimab sunirine-pvzy) for the treatment
FDA Grants Accelerated Approval to Hepcludex (bulevirtide-gmod) Treatment for Chronic Hepatitis Delta Virus (HDV)
FOSTER CITY, Calif. -- (BUSINESS WIRE) May 22, 2026 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepclu
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