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