Prasad left the Center for Biologics Evaluation and Research on July 29 after a conservative backlash to his handling of safety issues tied to Sarepta’s gene therapy, with President Trump ally Laura ...

Vinay Prasad is returning to his role overseeing vaccine, gene therapy and blood product regulation at the U.S. Food and Drug ...

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

Sarepta shares dropped as much as 5.2 per cent on Monday amid volatile trading, while those of Replimune — another gene ...

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.

FDA reinstates Vinay Prasad to lead CBER as gene therapy safety concerns spotlight regulatory challenges in biotech manufacturing.

TO APPRECIATE the dilemmas the Food and Drug Administration (FDA) faces when it reviews new drugs targeting rare diseases, ...

The shares of biotech companies fell after news that ousted regulator Vinay Prasad is set to go back to the US Food and Drug Administration.

US clinical-stage biotech Vor Bio has announced the appointment of Dallan Murray as chief commercial officer, effective ...

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

Haematological cancers are a recognised potential side effect with Skysona and were already mentioned in a boxed warning on ...