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 ...

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.

Sarepta Therapeutics announces voluntary pause all shipments of Elevidys for Duchenne muscular dystrophy in US: Cambridge, Massachusetts Wednesday, July 23, 2025, 12:00 Hrs [IST] ...

Roche Holding AG said on Tuesday it has paused all shipments of muscular disorder gene therapy Elevidys outside the U.S., ...

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 ...

There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.

Roche Holding AG temporarily halted shipments of its muscular disorder gene therapy, Elevidys, outside the U.S., mirroring its U.S. partner Sarepta Therapeutics. The pause affects orders relying on ...

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 lemonade stand is a fairly common sight for a hot summer day in July. Outside of Kitchen Concepts in Lexington, a white and yellow stand is doing more than just satisfying thirst.

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

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