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Latest From Michael Cipriano
Drug Safety: Sequential Surveillance Helps Regulatory Decision-Making, But Hurt By Premature Specification
Keeping Track: A Burst Of Breakthroughs, A Priority Review For Keytruda, And Some Supplemental Submissions
CDER's OHOP, as well as relevant CBER and CDRH staff, should be folded into OCE, which should have final sign-off on all oncology products, ASCO and Friends of Cancer Research say.
Refining A Controversial Endpoint: Sarepta Banking On Dystrophin Levels For Golodirsen Approval In DMD
Keeping Track: FDA Approves Novel HIV Treatment, New Dosing Regimen For Opdivo; Another Rare Pediatric Disease Designation For Prometic
The latest drug development news and highlights from our US FDA Performance Tracker.