Prasad and FDA Commissioner Marty Makary had asked Sarepta to cease shipping its treatment for Duchenne muscular dystrophy. At the FDA, Prasad will resume his role as head of CBER, but it’s unclear ...

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 ...

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, ...

CDC employees across all of the agency’s campuses will be teleworking today, after a gunman shot multiple rounds into four ...

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.Prasad had previously overruled his own scientific review ...

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 ...

Shares of several biotech firms fell in premarket trading Monday after reports that ousted U.S. Food and Drug Administration vaccine regulator Vinay Prasad will return to the agency.

In the wake of multiple patient deaths from liver injuries related to Sarepta Therapeutics’ AAV gene therapy platform, some ...