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

Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), has stepped down, with market analysts forecasting a boost to the cell and ...

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

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...

Vinay Prasad, FDA's top vaccine official, has resigned after three months amid criticism and controversy, especially concerning the FDA's handling of a gene therapy for Duchenne muscular dystrophy.

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

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

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