fda

U.S. FDA Approves Agios AQVESME (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemiaMarketed under AQVESME brand name…

2 days ago

Milestone Receives FDA Approval of CARDAMYST (etripamil) as First and Only Self-Administered Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)

First FDA approved treatment in 30+ years for more than 2 million Americans with PSVT Novel nasal spray designed to rapidly…

2 weeks ago

Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia

November 25, 2025 18:15 ET  | Source: Ascendis Pharma –  Prescription Drug User Fee Act (PDUFA) goal date extended by…

4 weeks ago

Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA Nephropathy

Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgANORIGIN Phase 3 trial met its primary endpoint at the…

2 months ago

Ofirnoflast (HT-6184) Receives Orphan Drug Designation from U.S. FDA for Myelodysplastic Syndromes

LEHI, Utah, Oct. 23, 2025 /PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering therapies that target the root causes…

2 months ago

Revolution Medicines Awarded Voucher for Daraxonrasib (RMC-6236) Under FDA Commissioner’s National Priority Voucher Pilot Program

REDWOOD CITY, Calif., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing…

2 months ago

Lords Mark Industries Ltd. secures US FDA Registration, Reinforces Indias Position in Global Healthcare Manufacturing

MUMBAI, India, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Lords Mark Industries Ltd., has received US FDA registration for its range…

2 months ago

FDA Approves Expanded Indication for UZEDY (risperidone) Extended-Release Injectable Suspension as a Treatment for Adults Living with Bipolar I Disorder

FDA approves UZEDY® (risperidone) extended-release injectable suspension for subcutaneous use as monotherapy or as adjunctive therapy to lithium or valproate…

2 months ago

FDA approves Roches Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase…

3 months ago

Press Release Biocartis NV: Biocartis Receives FDA Approval for the Idylla CDx MSI Test

PRESS RELEASE - 09/15/2025, 09:00 AM EDT Biocartis Receives FDA Approval for the Idylla™ CDx MSI Test First-ever fully automated,…

3 months ago