CBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out ...

Jefferies analysts said these detailed safety outcomes confirm the gene therapy's positive risk/benefit profile in ambulatory ...

This episode of Pharma Pulse covers Vinay Prasad’s return to lead the FDA’s biologics center after a brief resignation, new ...

Amyloid-beta exerted a pathogenic effect in cats with dementia, suggesting feline cognitive dysfunction syndrome may be a ...

WASHINGTON, DC – Dr. Vinay Prasad has been reinstated to a senior position at the Food and Drug Administration, according to ...

With a strong launch underway for a bladder cancer gene therapy, Ferring Pharmaceuticals is finding the kind of commercial ...

Vinay Prasad is once again head of the FDA’s Center for Biologics Evaluation and Research, after Laura Loomer led a campaign ...

Some oncologists and researchers have raised concerns about delays in the completion of confirmatory trials, but FDA now has new tools to push them ahead.

Vinay Prasad returns as FDA's CBER director after brief exit, raising questions on rare disease drug approvals and mRNA ...

Sarepta Therapeutics said Friday that the deaths of two patients taking its marketed gene therapy Elevidys® (delandistrogene ...

Prasad resigned from the FDA in July after backlash over his handling of Sarepta’s Elevidys gene therapy, which faced ...

The Food and Drug Administration (FDA) is hitting some speed bumps in implementing the Trump campaign agenda, and the ...