...as much turmoil among agency review staff as Woodcock’s intervention in the review of Exondys 51eteplirsen... ...overruled a decision by Office of Drug Evaluation I Director Ellis Unger to reject the Exondys 51... ...director of CDER Woodcock had the last word. While Califf wrote in 2016 that the Exondys 51...
...as much turmoil among agency review staff as Woodcock’s intervention in the review of Exondys 51eteplirsen... ...overruled a decision by Office of Drug Evaluation I Director Ellis Unger to reject the Exondys 51... ...and Research (CDER) Woodcock had the last word. While Califf wrote in 2016 that the Exondys 51...
...of whom pointed to the agency’s controversial 2016 approval of Sarepta’s first DMD drug, Exondys 51eteplirsen... ...“to a level that is reasonably likely to predict clinical benefit” (see “FDA Approves Sarepta’s Eteplirsen... ...fell $4.66 to $118.33 Wednesday.
Elizabeth S. Eaton, Staff Writer
Exondys 51 (Brand), AVI-4658 (Compound #), eteplirsen (Generic), Exondys 51...