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 Pfizer Inc.’s abrocitinib, Apellis Pharmaceuticals, Inc.’s pegcetacoplan and