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

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

The unusual move at FDA comes shortly after the agency's longtime vaccine chief was forced out over disagreements with Makary ...

Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking ...

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

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

A clinical trial is underway to assess the effectiveness and safety of sipavibart, AstraZeneca's long-acting monoclonal antibody designed to provide protection against Covid-19, as a potential ...

“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.

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

The President Donald Trump administration's request for Novavax Inc. to conduct new clinical trials for its COVID-19 vaccine ...