Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

The FDA appears to have won its staring contest with Sarepta over shipments of Elevidys, after the company blinked and agreed ...

Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.

Sarepta Therapeutics (SRPT) said late Monday it will pause all shipments of its Duchenne muscular dystrophy gene therapy, ...

Sarepta Therapeutics said it will voluntarily “and temporarily” pause all shipments of Elevidys® (delandistrogene ...

Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular ...

Sarepta Therapeutics will pause all U.S. shipments of its Elevidys gene therapy following the death of a muscular dystrophy patient who received an experimental treatment. Initially resisting ...

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 ...

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty ...

The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...