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Drugs.com - New Drug Approvals
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Last updated about 12 hours ago
FDA Grants Accelerated Approval to Lynozyfic (linvoseltamab-gcpt) for Treatment of Relapsed or Refractory Multiple Myeloma
about 14 hours ago
TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ...
Takeda Announces U.S. FDA Approval of Gammagard Liquid ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content
3 days ago
OSAKA, Japan and CAMBRIDGE, Massachusetts, June 30, 2025 – Takeda (TSE:4502/NYSE:TAK) today...
FDA Approves Gamifant (emapalumab-lzsg) as First-Ever Treatment for Adults and Children with Macrophage Activation Syndrome in Still's Disease
5 days ago
June 28, 2025 -- Sobi today announced that the U.S. Food and...
U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels for Breyanzi and Abecma
6 days ago
PRINCETON, N.J.--(BUSINESS WIRE) June 26, 2025 -- Bristol Myers Squibb (NYSE: BMY)...
Emmaus Life Sciences Receives FDA Approval for Endari Label Enhancements
7 days ago
Torrance CA, June 26, 2025 - Emmaus Life Sciences, Inc. (OTCQB: EMMA)...
FDA Approves Benlysta (belimumab) Autoinjector for Children with Active Lupus Nephritis
8 days ago
Philadelphia, PA June 24 2025 -- GSK plc (LSE/NYSE: GSK) today announced...
FDA Approves Expanded Indications for GE HealthCare’s Vizamyl PET Imaging Agent for Beta Amyloid Detection, Enabling More Precise Care for Alzheimer’s Patients
9 days ago
ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--Jun. 24, 2025-- GE HealthCare (Nasdaq: GEHC) today announced...
Datroway Approved in the U.S. as First TROP2 Directed Therapy for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
9 days ago
Tokyo and Basking Ridge, NJ – June 23, 2025 – Datroway (datopotamab...
Dupixent (dupilumab) Approved in the U.S. as the Only Targeted Medicine to Treat Patients with Bullous Pemphigoid (BP)
13 days ago
TARRYTOWN, N.Y. and PARIS, June 20, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals...
FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria
14 days ago
BOSTON, Massachusetts and Cambridge, UK – June 19, 2025 – Cycle Pharmaceuticals...
FDA Approves Yeztugo (lenacapavir) as the First and Only HIV Prevention Option Offering 6 Months of Protection
15 days ago
FOSTER CITY, Calif.--(BUSINESS WIRE) June 18, 2025 -- Gilead Sciences, Inc. (Nasdaq...
Incyte Announces FDA Approval of Monjuvi (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma
15 days ago
WILMINGTON, Del.--(BUSINESS WIRE)--Jun. 18, 2025-- Incyte (Nasdaq:INCY) today announced that the U.S...