Tag: fda

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…

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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…

GlobeNews Wire

Keros Announces U.S. FDA Orphan Drug Designation Granted to KER-065 for the Treatment of Duchenne Muscular Dystrophy

August 20, 2025 09:48 ET  | Source: Keros Therapeutics, Inc. LEXINGTON, Mass.,…

GlobeNews Wire

Anbogen Receives FDA Clearance to Initiate Phase 1/2 Trial of ABT-301 Triplet Therapy for Advanced Colorectal Cancer

TAIPEI, Aug. 4, 2025 /PRNewswire/ -- Anbogen Therapeutics today announced that the…

Zenara Pharma Receives U.S. FDA Approval for First Generic of Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity

HYDERABAD, India, August 1, 2025 /PRNewswire/ -- Zenara Pharma Private Limited ("Zenara"), a Biophore…