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, ...

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

Spinal muscular atrophy (SMA) is a genetic neuromuscular disease affecting specialized nerve cells that control voluntary ...

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 ...

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

Vinay Prasad, a former critic of U.S. COVID-19 policies, returns to the FDA's Center for Biologics Evaluation and Research after briefly leaving. His tenure drew criticism, notably over the handling ...

At the U.S. Food and Drug Administration's (FDA) request, Vinay Prasad is returning to the role of director of the Center for ...

Vinay Prasad, a top vaccine regulator ousted from the Food and Drug Administration (FDA) late last month, is set to return to ...

After exiting the FDA less than two weeks ago for unclear reasons, Vinay Prasad is once again director of the Center for ...

Vinay Prasad, previously critical of U.S. COVID-19 policies, has returned to his role managing vaccine and gene therapy regulation at the FDA, days after his departure. His leadership saw controversy ...