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 ...

Hong Kong-based CSPC will receive $120 million from Madrigal under the deal. Elsewhere, Apellis and PTC Therapeutics won FDA approvals.

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

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

Loomer had slammed Prasad for allegedly denying drug approvals for rare diseases, and for his past support of left-leaning figures like Senator Bernie Sanders ...

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 ...

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 ...