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.

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 ...

Prasad resigned from the FDA in July after backlash over his handling of Sarepta’s Elevidys gene therapy, which faced ...

Ukraine and its European allies sought on Sunday to present a united front ahead of a meeting this week between President ...

The Food and Drug Administration (FDA) is hitting some speed bumps in implementing the Trump campaign agenda, and the ...

Dr. Vinay Prasad’s rehiring was an unusual instance of a federal official targeted by the right-wing activist Laura Loomer ...

Vinay Prasad, who was recently ousted as the top vaccine and gene therapy regulator at the US Food and Drug Administration, is returning to his role, the Department of Health and Human Services said ...

Sarepta Therapeutics Inc.’s shares soared after the US biotech reported revenue that beat estimates, which analysts ...

The FDA had halted use in older adults while it investigated reports of side effects. The vaccine’s label now carries new ...

Scientists have found that lithium orotate — which is different from the kind of lithium typically used to treat mental health conditions — not only stopped the brain disease in mice but also reversed ...