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

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

Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...

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

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

The agency suggested that clinical trials in humans may be required for updated Covid shots, raising questions about whether ...

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.

Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which ...

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

Because the coronavirus continually mutates, manufacturers follow instructions from FDA to make one change each year to their recipe — which strain to target — just like flu vaccines.

The Department of Health and Human Services says it will require new vaccines to be tested against a placebo, which could ...