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 ...

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

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

PTC Therapeutics faces pivotal FDA decisions for approvals that could potentially transform their long-term revenues. Click ...

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

From the meme stock revival to Trump's Fed feud, Peter Hodson looks at some of the summer's more bizarre trends ...

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

The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.

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

The U.S. Food and Drug Administration's (FDA) top vaccine official is stepping down after just three months in a role that ...

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