The FDA is allowing Sarepta to resume shipments of Elevidys (delandistrogene moxeparvovec) to ambulatory patients with Duchenne muscular dystrophy.

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

I do not work for Big Pharma. I work in support of President Trump on the outside of the administration,’ Loomer tells The ...

The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.

Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.

Trump appeared to acknowledge in the interview that his ruthless mass deportation campaign is hurting farms, which rely on ...

Vinay Prasad, M.D., has left the FDA less than three months into the role as director of the Center for Biologics Evaluation ...

As Laura Loomer wields a terrifying amount of power, other far-right influencers are accusing her of being a “plant.” ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and ...

Hansa Biosciences’ Idefirix (imlifidase) has reduced patients’ antibodies to a level that allows dosing in patients with Duchenne muscular dystrophy (DMD) with Sarepta and Roche’s Elevidys ...

Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), ...