Sarepta's Additional Data Doesn't Sway FDA On Eteplirsen
This article was originally published in The Pink Sheet Daily
Agency reviewers raise more concerns about efficacy of proposed Duchenne muscular dystrophy treatment despite new information.
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Advocates also worry that long follow-up times could prevent participation in future clinical trials.
EMA and payers want to know more about daily life improvements from US FDA-approved Duchenne muscular dystrophy treatment.