Keeping Track: Terlipressin Falls Short Of US FDA Approval; Novel NDAs From Pfizer And Apellis; New BTDs For Sanofi, BeyondSpring

The US Food and Drug Administration’s only major approval decision in the past week was negative – a complete response letter for Mallinckrodt plc’s terlipressin – but some new NDA submissions helped to pick up the newsflow.

In an extremely quiet week for FDA actions, company submissions took over the newsflow, led by NDA announcements for