Posted by Michael Wonder on 16 Nov 2020
Apellis announces FDA acceptance and priority review of the new drug application for pegcetacoplan for the treatment of PNH
16 November 2020 - FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.
Apellis Pharmaceuticals today announced that the U.S. FDA has accepted and granted priority review designation for the new drug application for pegcetacoplan for the treatment of paroxysmal nocturnal haemoglobinuria.
The Prescription Drug User Fee Act target action date is 14 May 2021.
