The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 ...

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

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

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

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

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 US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit ...

Data shows around 300 deaths a week in mid-April as the FDA rolls out more-stringent vaccine approval rules.

Trump admin's new FDA update limits annual COVID shots to high-risk groups, ending routine access for healthy kids and adults ...