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

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use of two Covid-19 vaccines, newly released documents show.

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...

According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

Note that some links may require registration or subscription. A 35-year-old gastroenterologist pleaded guilty to sexually ...

The nascent leadership team assembled by Kennedy consists of highly talented and respected experts in their fields. Let’s ...

But Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, was skeptical of the treatment and decided unilaterally to cancel the meeting, according to a person ...

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

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 ...