News

FDA’s Prasad Exits Following Political Backlash Over Sarepta

Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...

The Sarepta Mugging and Drug Innovation

The Trump FDA tries to kill a therapy that has helped boys with a deadly diagnosis.
Fierce Pharma3d

Vinay Prasad departs FDA amid conservative criticism, controversy over Sarepta gene therapy

Vinay Prasad, M.D., has left the FDA less than three months into the role as director of the Center for Biologics Evaluation ...

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 ...

FDA Says Sarepta Can Resume Gene Therapy in Some Patients

In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...
STAT4d

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, ...
Opinion

On Sarepta, a Welcome FDA Reversal

After our editorial, the agency relents to allow a Duchenne treatment.

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
Fierce Pharma1d

Untangling Sarepta’s gene therapy fallout and a growing trust deficit

Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...