News

FDA partially lifts hold on Sarepta's Duchenne gene therapy after community outcry
The FDA has partially reversed course on its push to halt shipments of a controversial gene therapy made by Sarepta ...
Fierce Pharma6h
FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients
On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...
Sarepta resumes shipping of gene therapy Elevidys to patients who can walk
Sarepta Therapeutics said on Monday it will resume shipping of its gene therapy Elevidys to patients with a rare muscular ...
US FDA recommends removal of hold on Sarepta's Elevidys in some patients
The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...
Asianet Newsable on MSN23h
Retail Bulls Stick With Sarepta After 8-Year-Old Patient’s Death Deemed Unrelated To DMD Gene Therapy
The update comes as Sarepta faces mounting regulatory scrutiny, including an ongoing FDA investigation and a recommendation ...
News Nation on MSN14h
Parents urge FDA to restore gene therapy after distribution pause
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.