Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News and ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

Sarepta Therapeutics (NASDAQ:SRPT) resumed its recent sell-off on Thursday after Endpoints News reported that the FDA would ...

According to Endpoints News, FDA officials stated that the Center for Biologics Evaluation and Research (CBER) review staff are "unanimous" that Elevidys should never return to market. The report ...

US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether Sarepta Therapeutics’ gene therapy, Elevidys, should remain on the market, following recent patient ...