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 ...

The US Food and Drug Administration approved Sarepta’s Exondys 51 (eteplirsen) injection, making it the first drug available for the rare genetic muscle-wasting disease in the country.

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' Elevidys for DMD shows ... and exon 45 skipping, EXONDYS 51, VYONDYS 53 and AMONDYS 45, Elevidys has a full approval to treat ambulatory patients at least four years old ...

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, ...