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

For years, U.S. vaccine experts have issued a universal recommendation for Covid vaccines. That could change soon.

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

The independent experts will meet on May 22 to discuss updates to the COVID-19 vaccine for the upcoming season.

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

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

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

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 ...

Dr. Vinay Prasad was an outspoken critic of the FDA’s response to the pandemic, including the former vaccine chief, Dr. Peter ...

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

The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...

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