Breakthrough Therapy

Cancer Treatment Advances: FDA Recognizes Breakthrough Potential of BNT323/DB-1303 for Endometrial Cancer

(IN BRIEF) BioNTech and Duality Biologics have received Breakthrough Therapy designation from the FDA for their antibody-drug conjugate (ADC) candidate,…

4 months ago

Roche: US FDA granted Breakthrough Therapy Designation to Hemlibra® for people with haemophilia A without factor VIII inhibitors

Designation based on phase III HAVEN 3 study demonstrating Hemlibra prophylaxis significantly reduced bleeds compared to no prophylaxis First medicine…

6 years ago

Sanofi and its subsidiary Genzyme announced that US FDA granted Breakthrough Therapy designation to olipudase alfa

Investigational Enzyme Replacement Therapy to Treat Non-Neurological Manifestations which characterize Niemann-Pick Type B PARIS, 5-6-2015 — /EuropaWire/ — Sanofi and its…

9 years ago