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

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

Prasad, a longtime critic of the FDA’s leniency in drug approvals, joined the agency in May. WASHINGTON — The Food and Drug ...

Vinay Prasad, the top vaccine regulator and chief scientific officer at the Food and Drug Administration (FDA) and a critic ...

Donald Trump reportedly ignored calls from Health Secretary Robert F. Kennedy Jr. not to fire the top vaccine official at the Food and Drug Administration after a pressure campaign from far-right ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will report second ...

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

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

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

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

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

Dr Vinay Prasad has resigned from the FDA after less than three months amid controversy over Sarepta Therapeutics' gene ...