Sarepta is a biopharmaceutical company focused on developing treatments for rare diseases. Sarepta's most important product is Elevidys, a therapy for the treatment of Duchenne muscular dystrophy. As ...

The U.S. Food and Drug Administration (FDA) has recommended lifting the voluntary clinical hold on Elevidys for ambulatory patients with Duchenne Muscular Dystrophy (DMD), following a thorough ...

Vinay Prasad's interim replacement has concerns about same drug that drove him out. NIH director says employee critics ...

Dr George Tidmarsh, a former pharmaceutical executive who joined the FDA this month, will take over Prasad’s role temporarily.

Two major health agencies are facing leadership reshuffles, with the resignations of the FDA’s Vinay Prasad and NICE’s Dr Sam Roberts.

PTC Therapeutics faces pivotal FDA decisions for approvals that could potentially transform their long-term revenues. Click ...

Indian-origin scientist Vinay Prasad resigned as the FDA's vaccine and gene therapy chief in just three months after backlash ...

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

A biopharmaceutical research company with ties in Andover has laid off a third of its workforce as one of the leaders in gene therapy goes through a “strategic ...

Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A ...

A controversial hematologist-oncologist who joined FDA this spring and quickly became its top regulator has left the ...