News

FDA’s Prasad Exits After Sarepta Gene Therapy Controversy
Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...
Sarepta finally gets some good news: A patient death wasn’t its DMD drug’s fault.
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
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Pharmalittle: We’re reading about a new Novo Nordisk CEO, an FDA reversal on Sarepta, and more
Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...
InnovationRx: Sarepta Blinks In Showdown With FDA
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
Sarepta Stock Rises Despite Downgrade and FDA Probe. The Crisis Explained.
Sarepta shares gained even though the U.S. Food and Drug Administration said late Friday that it was probing the death of an ...
BioSpace4d
Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
Sarepta fails to win EU backing for muscle disorder gene therapy
Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...
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FDA panel stirs backlash for SSRI use during pregnancy
Morning. Today, we discuss how Duchenne patients and their families are responding to the shelving of Sarepta Therapeutics’ ...