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

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

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

Such appeasement efforts proved insufficient to protect him from rival forces in the Republican Party, if not also in the ...

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 ...

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 ...

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

It is hard to imagine someone more equipped and more dedicated to vetting treatments than Vinay Prasad,” writes his former ...

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

The fast-selling GLP-1 drug matched Lilly's older medicine Trulicity in a closely watched cardiovascular outcomes trial, ...

Gene Therapy Market Gene therapy market surges on breakthroughs in genome editing, rising chronic & genetic disease cases, regulatory appro ...

The immediate ebullient reaction to Vinay Prasad’s ouster is understandable, and may ultimately be the correct one, Adam ...