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 ...

FDA vaccines chief Vinay Prasad limited broader use of COVID vaccines, citing reduced risk and data concerns. Read more here.

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

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

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

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

The US Food and Drug Administration (FDA) has provided an update on the risk of myocarditis after receiving an mRNA COVID-19 ...

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 ...

Health Secretary Robert F. Kennedy Jr. endorsed the expanded use of RSV vaccines for people 50 through 59 years old who are ...