In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from ...

Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...

The drastic cost-cutting move follows the deaths of two teenagers that forced the company to restrict usage of its gene therapy for Duchenne muscular dystrophy.

The leader of the U.S. FDA's division that oversees vaccines, Vinay Prasad, overruled the recommendations of his agency's staff by limiting broader use of two COVID-19 vaccines. The FDA scientists had ...

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and ...

The head of the US Food and Drug Administration said the agency will “take a hard look” at a gene therapy from Sarepta Therapeutics Inc. after two patient deaths, adding pressure to the biotech ...

Participants in trials of BrainStorm Cell Therapeutics' NurOwn filed a Citizens’ Petition with the FDA earlier this month ...

FDA vaccine head Vinay Prasad restricted Moderna and Novavax COVID vaccines to high-risk groups, overriding staff advice amid concerns about rare side effects.