Tag: fda

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…

PRNW Agency

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…

GlobeNews Wire

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,…

Business Wire

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…

GlobeNews Wire

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…

PRNW Agency

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

ZHUBEI CITY, June 17, 2025 /PRNewswire/ -- Brain Navi Biotechnology, a medical robotics…

PRNW Agency

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…

Business Wire

Press Release: Rilzabrutinib granted orphan drug designation in the US for sickle cell disease

Rilzabrutinib granted orphan drug designation in the US for sickle cell disease…

GlobeNews Wire