Tag: fda

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