Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

The U.S. Food and Drug Administration has tapped Dr. Vinay Prasad to lead the agency’s Center for Biologics Evaluation and ...

Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S.

A panel of Food and Drug Adminsitration advisers will meet May 22 to discuss updating the formula of COVID-19 vaccines ahead of the fall and winter season, according to a draft notice posted Wednesday ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

Leaders at the FDA, HHS and elsewhere are putting guardrails around COVID-19 boosters, which could mean delayed shots or ...

Novavax said on Thursday discussions with the U.S. health regulator on its COVID-19 shot are ongoing and a pathway to ...

Vinay Prasad, named to lead the FDA agency tasked with regulating vaccines and gene therapy, has made controversial comments ...

(Reuters) -The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts to discuss COVID-19 ...

Dr. Vinay Prasad, the FDA's new vaccine chief, has been accused of spreading misinformation about Covid vaccines.

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...

A new vaccine developed by Moderna aims to protect against both flu and COVID-19 with just one shot. Early studies suggest ...