The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency ...

Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy ...

Kriya is advancing a host of gene therapies for a wide variety of chronic diseases, including geographic atrophy, trigeminal ...

The deaths prompted the FDA to ask Sarepta to stop shipping Elevidys for all patients, but the company refused to do so. Days later, it changed tack in order to maintain what it said was a “positive ...

Sarepta (SRPT), in a letter dated August 14 to the FDA, responded to the Citizen Petition related to Elevidys. The letter states in part: “The Petition misrepresents the number of treatment-related ...