Sarepta shares gained even though the U.S. Food and Drug Administration said late Friday that it was probing the death of an ...

The Trump FDA tries to kill a therapy that has helped boys with a deadly diagnosis.

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

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

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

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...

The FDA is investigating the death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics to treat Duchenne muscular dystrophy. The child died June 7, prompting ...

The Food and Drug Administration is investigating Sarepta’s gene therapy products following reports of a third death from acute liver failure.

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