The anticipated rollout of updated Covid vaccines this fall might be at risk after a change by Health and Human Services ...

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

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

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

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

Moderna is deprioritizing its flu/COVID combination vaccine in younger adults amid a push to cut about $1.5 billion from its ...

The Food and Drug Administration was set to release new guidance on COVID booster shots ahead of the fall season, but that's ...

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.

Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously ...

Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the ...