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…
Leo Cancer Care Receives FDA 510(k) Clearance for Marie – A Revolutionary Upright Radiotherapy Platform
MIDDLETON, Wis., July 29, 2025 /PRNewswire/ --Â Leo Cancer Care, a leader in…
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…
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,…
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…
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…
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,…
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 Â | Source: Ultragenyx Pharmaceutical Inc. Complete Response…
Sirtex Medical’s SIR-Spheres Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma
Expanded indication makes SIR-Spheres® the first and only radioembolization therapy in the…
AB Science: Masitinib receives FDA and EMA authorization for confirmatory phase 3 trial in metastatic castrate-resistant prostate cancer
PRESS RELEASE MASITINIB RECEIVES FDA AND EMA AUTHORIZATION FOR CONFIRMATORY PHASE 3…