Keyword: Janet Woodcock

FDA expert lashes out at 'worrisome' Sarepta approval in JAMA

External FDA expert Aaron Kesselheim, who advised against the regulator approving Sarepta’s new and highly controversial Duchenne med Exondys 51 (eteplirsen), has used a JAMA article to hit out at the regulator’s processes and the biotech that led to its green light last month