The latest shake-up at the FDA forced out the top two officials in charge of reviewing cell and gene therapies, analysts said.

The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about ...

Shares of gene editing companies were largely steady in the premarket on Friday after the FDA’s Center for Biologics Research ...

The death of a boy with Duchenne muscular dystrophy, tied to a gene therapy, is above all a tragedy. But it is also ...

Duchenne muscular dystrophy families are sharing stories about Elevidys complications on social media. But they aren’t ...

In this week’s edition of InnovationRx, we look at the dangers of RFK Jr.’s vaccine advisory committee, how Trump’s visa ban ...

Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the ...

Diaylsis-technology maker Fresenius Medical Care could end up benefiting from blockbuster obesity drugs, according to its chief executive, contrary to concerns that such treatments could deplete ...

The pending deal was rumored overnight after a report from the Financial Times, spurring analysts to speculate that if true, ...

Ticker: Second patient death reported with gene therapy for muscular dystrophy; Salmonella poisoning linked to pistachio ...

Shares of Sarepta Therapeutics have plunged again after the drugmaker reported a second death in connection with its gene ...

How the U.S. FDA might respond became a serious question for Wall Street as Sarepta Therapeutics Inc. made known a second death due to acute liver failure with gene therapy Elevidys (delandistrogene ...