fda

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 U.S. Food and Drug Administration (FDA) has approved…

6 days ago

Valneva Announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ in Elderly and Updates to the Prescribing Information

Saint Herblain (France), August 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced…

1 week ago

Galapagos NV Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to GLPG5101 for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

Mechelen, Belgium; August 6, 2025, 7:30 CET; regulated information – inside information – Galapagos NV (Euronext & NASDAQ: GLPG) today…

1 week ago

Leo Cancer Care Receives FDA 510(k) Clearance for Marie – A Revolutionary Upright Radiotherapy Platform

MIDDLETON, Wis., July 29, 2025 /PRNewswire/ -- Leo Cancer Care, a leader in upright radiotherapy solutions, today announces that its flagship…

2 weeks ago

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 company, today announced that it has received final…

2 weeks ago

FDA Approves Apellis EMPAVELI (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older

Proven efficacy across all three key markers of disease—68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of…

2 weeks ago

Shanton Receives Fast Track Designation from US FDA for Refractory Gout Program

SAP-001 is Shanton's lead investigational compound with First- and Best-in-Class potential in uncontrolled gout SINGAPORE and PRINCETON, N.J., July 25,…

3 weeks ago

AB Science has received approval from several European countries to initiate the confirmatory phase 3 study of masitinib in ALS

PRESS RELEASE AB SCIENCE HAS RECEIVED APPROVAL FROM SEVERAL EUROPEAN COUNTRIES TO INITIATE THE CONFIRMATORY PHASE 3 STUDY OF MASITINIB…

3 weeks ago

UNCY Investors Have Opportunity to Join Unicycive Therapeutics, Inc. Fraud Investigation With the Schall Law Firm

LOS ANGELES--(BUSINESS WIRE)--$UNCY--The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf…

4 weeks ago

Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)

July 11, 2025 16:30 ET  | Source: Ultragenyx Pharmaceutical Inc. Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls…

1 month ago