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 ...

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 ...
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 ...

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, ...
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 ...
Fierce Pharma12d

Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

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 ...
STAT5d

FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt

The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
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 ...