Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

In a major policy shift, federal health officials anticipate the shots will be made available to adults 65 and older as well ...

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...

The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the ...

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for ...

"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at ...

The agency will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...

Advisers to the U.S. Food and Drug Administration will discuss recommendations for updated COVID-19 vaccines ahead of the ...

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.