Exondys 51

Controversy surrounds Exondys 51 approval: What to knowNew medicine for Duchenne muscular dystrophy raises questions. Here’s whose covering it and why.
Incremental clinical advances for Duchenne Muscular DystrophyJust last year, the FDA approved Exondys 51 (eteplirsen) for DMD, over the recommendations of FDA scientists and an external scientific advisory committee. Read more.
FDA approves first drug for Duchenne muscular dystrophyEven though an FDA panel recommended against approving a new drug to treat Duchenne muscular dystrophy in April, the agency granted accelerated approval to eteplirsen injection (Exondys 51, Sarepta Therapeutics) in mid-September.