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

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

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

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

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

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

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

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

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

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

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

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