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

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

The abrupt exit of the former CBER director, who quickly made his mark at the agency with several high-profile and ...

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

Dr Vinay Prasad. the U.S. Food and Drug Administration's (FDA) top official, has left the agency just three months after ...

After turning down several new drugs and restricting use of another, Dr. Vinay Prasad drew the ire of the right-wing ...

Prasad, an oncologist who previously criticised the FDA and was a fierce critic of US Covid-19 vaccine and mask mandates, had ...

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.

While MSN reports that Sarepta’s stock price began to rise on Monday on the heels of the announcement, 5 the company is still facing challenges. Shipments of the gene therapy for non-ambulatory ...

Shares of Sarepta Therapeutics Inc. (SRPT) traded 20% higher on Tuesday afternoon after the U.S. Food and Drug Administration ...