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

Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...

Prasad’s departure, confirmed to Pharmaceutical Technology by a department for Human Health and Services (HHS) spokesperson, ...

In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and ...

The FDA's top vaccine and gene therapy official resigned Tuesday after a public campaign against him led by right-wing influencer Laura Loomer.

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

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

After our editorial, the agency relents to allow a Duchenne treatment.

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

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...