...she made while head of FDA’s CDER, including her intervention in the review of Exondys 51 eteplirsen...

...as much turmoil among agency review staff as Woodcock’s intervention in the review of Exondys 51 eteplirsen...
...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 51 eteplirsen...
...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...

...in to grant accelerated approval to Exondys 51 eteplirsen...

...since then.Sarepta Therapeutics Inc. (NASDAQ:SRPT) has the only two innovative, FDA-approved drugs for DMD: Exondys 51 eteplirsen and...

...a controversy over the review of Exondys 51 eteplirsen...

...patient advocacy group GoFAR and the Muscular Dystrophy Association Venture Philanthropy Fund.Best known for Exondys 51 eteplirsen...

...the application. About 8% of DMD patients are exon 45-amenable; Sarepta’s marketed exon-skipping therapies Exondys 51 eteplirsen...

...the gene therapy and gained an option outside the U.S. to Sarepta’s DMD drugs Exondys 51 eteplirsen...

...of whom pointed to the agency’s controversial 2016 approval of Sarepta’s first DMD drug, Exondys 51 eteplirsen...
...“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...