The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

Bentracimab is an investigational human monoclonal antibody fragment that binds to ticagrelor, an oral P2Y 12 platelet inhibitor, reversing its antiplatelet effects. The BLA submission is ...