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Sarepta Will Resume Gene Therapy Shipments

Bloomberg on MSN · 5h

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 handling of Sarepta Therapeutics Inc.’s gene therapy.

The Associated Press on MSN · 1d

Sarepta will resume gene therapy shipments after FDA review of recent patient death

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy.

Reuters on MSN · 11d

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died,

11h

Sarepta soars after FDA says some patients can get Elevidys

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

14hon MSN

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 ...

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 ...

6d

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, ...

1don MSN

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 ...

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 ...

4don MSN

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 ...

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’ ...

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