fda

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…

3 months 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 months 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 months 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…

3 months 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…

3 months ago

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 U.S. approved to treat both unresectable hepatocellular carcinoma…

3 months ago

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 TRIAL IN METASTATIC CASTRATE-RESISTANT PROSTATE CANCER, WITH BIOMARKER-DRIVEN…

3 months ago

Brain Navi achieves U.S. FDA approval for neurosurgical robot NaoTrac

ZHUBEI CITY, June 17, 2025 /PRNewswire/ -- Brain Navi Biotechnology, a medical robotics company founded in 2015 in Taiwan by surgeon…

4 months ago

Circle Pharma Receives FDA Orphan Drug Designation for CID-078 for the Treatment of Small Cell Lung Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--#Biotech--Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, today announced that the…

4 months ago

Merry Life Launches Global Phase II Trial of TML-6, The First Drug Targeted at Autolysosome pathway for Therapy of Alzheimer’s Disease

TAINAN, June 13, 2025 /PRNewswire/ -- Merry Life Biomedical Company announces the launch of its global Phase II clinical trial…

4 months ago