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

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

Vinay Prasad resumes leadership at the FDA’s CBER two weeks after he resigned amid cell and gene therapy controversy.

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

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

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

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

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 ...

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

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

Plus more pharma news from the Pharmalittle newsletter.

Semiconductor giant Nvidia dropped 1% in premarket trading and Advanced Micro Devices lost 2%. A U.S. official told Reuters ...