6. Approve the request and, optionally, add a comment, as shown in Figure F. (If an approver rejects the request, you’ll need to address their concerns and then go through the approval process ...

Stealth BioTherapeutics’ 16.5-month priority review cycle has ended in rejection. After delays, Stealth said the FDA turned down its request but set out a path to accelerated approval, leading ...

Amgen now says that’s exactly what the FDA has done, with the request to flip the accelerated approval into a full approval rejected with a complete response letter, according to a Dec. 26 news ...