CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.

Key Points Sarepta Therapeutics' most crucial product is turning out to have severe safety issues. The company's efforts to improve its situation were well received, but this victory didn't last long.

Bank of America downgraded Sarepta Therapeutics (NASDAQ:SRPT) to Underperform from Neutral on Wednesday, becoming the latest ...

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

Sarepta pauses U.S. Elevidys shipments to complete FDA-requested safety label updates, aiming to resume distribution in the fourth quarter.