The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...

Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.

Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...

In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...

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

Sarepta (NASDAQ:SRPT) stock, Replimune (NASDAQ:REPL) stock and Capricor (CAPR) stock surge as FDA's biologics head exits abruptly. Read more here.

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

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

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

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

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...

Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task ...