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 ...

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.

The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

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

In a shift away from next-generation Covid-19 vaccines, the Trump administration is investing $500 million in a vaccine ...

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

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

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

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