In our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or the Agency) that may affect ...

Sarepta’s troubles had nothing to do with Arrowhead’s assets, and yet both companies have seen their stock prices decline ...

Amyloid-beta exerted a pathogenic effect in cats with dementia, suggesting feline cognitive dysfunction syndrome may be a ...

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 ...

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

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

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

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

At 05:45 a.m. ET, Dow E-minis were up 98 points, or 0.22%, with 7,922 contracts changing hands, S&P 500 E-minis were up 6.25 ...

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 ...

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