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The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency ...

Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy ...

The deaths prompted the FDA to ask Sarepta to stop shipping Elevidys for all patients, but the company refused to do so. Days later, it changed tack in order to maintain what it said was a “positive ...

Arrowhead Pharmaceuticals stock tumbled Thursday after Sarepta Therapeutics liquefied its entire stake in the smaller biotech ...

Liquidating its stake in Arrowhead helps Sarepta cover a milestone payment and secure what one analyst described as ...

Jefferies analysts said these detailed safety outcomes confirm the gene therapy's positive risk/benefit profile in ambulatory ...

WASHINGTON, DC – Dr. Vinay Prasad has been reinstated to a senior position at the Food and Drug Administration, according to ...

With a strong launch underway for a bladder cancer gene therapy, Ferring is finding the kind of commercial success that’s ...

Vinay Prasad is once again head of the FDA’s Center for Biologics Evaluation and Research, after Laura Loomer led a campaign ...

Some oncologists and researchers have raised concerns about delays in the completion of confirmatory trials, but FDA now has new tools to push them ahead.

Vinay Prasad returns as FDA's CBER director after brief exit, raising questions on rare disease drug approvals and mRNA ...