A biopharmaceutical research company with ties in Andover has laid off a third of its workforce as one of the industry leaders in gene therapy goes through a “strategic restructuring.” Sarepta ...

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...

The FDA greenlit multiple new drugs this month and issued some notable label expansions including for Eli Lilly’s Kisunla.

Donald Trump reportedly ignored calls from Health Secretary Robert F. Kennedy Jr. not to fire the top vaccine official at the ...

A senior official at the US Food and Drug Administration has suddenly resigned after only three months in the job. Vinay Prasad’s departure followed controversy over a treatment for Duchenne muscular ...

This week on "The Readout LOUD," STAT's biotech reporters parse what Vinay Prasad's ouster means for biotech and the FDA.

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

Tidmarsh will temporarily guide CBER’s regulatory activities while the FDA searches for a permanent department lead.

The former official, Vinay Prasad, had been on the job three months and had recently come under attack by conservative ...

On Dr. Prasad’s new watch, the FDA has torpedoed several promising treatments for rare and deadly diseases. This includes an immunotherapy shot that helped a third of advanced melanoma patients who ...

Other changes under Prasad, who was also the agency's chief medical and science officer, included a new policy limiting the ...

Indian-origin scientist Vinay Prasad resigned as the FDA's vaccine and gene therapy chief in just three months after backlash ...