Elevidys is an adeno-associated virus vector-based gene therapy that uses Sarepta’s AAVrh74 Platform Technology to treat DMD, ...

In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...

The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...

The founder and former CEO of several pharmaceutical companies, Tidmarsh was tapped by FDA Commissioner Marty Makary, MD, MPH ...

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

The FDA is investigating the death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics to treat Duchenne muscular dystrophy. The child died June 7, prompting ...

The Food and Drug Administration is investigating Sarepta’s gene therapy products following reports of a third death from acute liver failure.

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...

The Food and Drug Administration has paused distribution of the gene therapy Elevidys following the death of a third patient ...

Sarepta Therapeutics now trades at book value with strong cash and cost-cutting plans, while ELEVIDYS may regain broader use.