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

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

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 ...

The head of the FDA reiterated that the agency is applying a more skeptical approach to this year’s round of COVID-19 vaccine boosters.

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

the FDA’s former vaccine chief, saying on Twitter, now X, in 2022 that Marks “might be the worst FDA regulator in modern ...

Prasad’s appointment to lead the Center for Biologics Evaluation and Research comes as the FDA says it will impose new ...

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

The independent experts will meet on May 22 to discuss updates to the COVID-19 vaccine for the upcoming season. Later this month, the FDA will convene its external vaccine advisors to decide on the ...

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

If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

Prasad has long criticized the FDA for granting emergency use authorization for COVID-19 vaccine boosters, saying last year that Marks was "either incompetent or corrupt to authorize a booster ...