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 ...

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 ...

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

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

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.

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

On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its ...

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

Novavax says its closely watched COVID-19 vaccine is on track for full U.S. approval after additional discussions with the ...