U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...

In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take its gene therapy Elevidys again.

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

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

Vor Bio appoints Dallan Murray as chief commercial officer, leveraging his extensive experience to drive commercialization ...

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

Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...

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 ...

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...

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