Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

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

Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...

Shares of Sarepta Therapeutics fell as much as 8% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the ...

Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...

By Zachary Stieber Contributing Writer In a reversal, the drugmaker Sarepta Therapeutics said July 21 it is stopping all ...

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the ...

A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand. | A brief skirmish between ...

Sarepta will stop shipping its Duchenne muscular dystrophy gene therapy Elevidys following ongoing discussions with the FDA over safety labeling. The drugmaker said the pause, effective July 22, will ...

Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.

The FDA had made the request Friday, which Sarepta initially rebuffed, following the death of a third patient treated with one of the firm's gene therapies.