In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the ...

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

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...

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

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

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