A top official at the Food and Drug Administration steps down after the agency changes course on a treatment for Duchenne ...

The gene therapy chief wanted to block fast-track drug approvals.

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

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.

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 ...

Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office ...

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

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 ...