The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for ...

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.

Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...

Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt ...

Also on Friday, the Food and Drug Administration informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, which is approved to treat a different type of ...

Sarepta stock (SRPT) declined 5% in premarket trade, after falling 36% on Friday, when it disclosed a patient death due to liver failure.

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

Sarepta Therapeutics announced late Friday evening that it will not comply with the Food and Drug Administration's ...

Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...