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

The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine — the nation's only traditional ...

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

A Department of Health and Human Services spokesperson called the move "a radical departure from past practices." ...

“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...

The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

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

Have you ever wondered about what became of COVID vaccine companies after the pandemic settled down? Find out in this article ...

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...

Researchers aim to develop a universal vaccine platform that could protect against both COVID-19 and influenza without annual ...