Controversy has dogged Sarepta’s Duchenne muscular dystrophy therapy Exondys 51 since its approval, and it’s not out of the woods yet. US cost-effectiveness watchdog the Institute for Clinical ...
In a note to investors, SVB Leerink analyst Joseph Schwartz suggested that the 'questionable' approval of Sarepta's Exondys 51 may have played a role in the FDA's decision to turn down golodirsen.
The Sarepta and Biogen therapies mentioned are, respectively, Exondys 51 (eteplirsen) and Aduhelm (aducanumab). They are used for Duchenne muscular dystrophy and Alzheimer's disease. The FDA's ...
Sarepta Therapeutics has decided not to continue the development of vesleteplirsen, a follow-up to its Duchenne muscular dystrophy (DMD) therapy Exondys 51. The drug – formerly known as SRP-5051 ...
Biogen’s Aduhelm, Sarepta’s Exondys 51, along with Covis Pharma’s Makena were all cleared quickly by the US Food and Drug Administration despite weak evidence and disagreements among reviewers, ...
Sarepta Therapeutics ... genetic therapeutic modalities for the treatment of rare diseases. It offers EXONDYS 51 injection to treat duchenne muscular dystrophy (duchenne) in patients with ...