Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

Andrew Cuomo faces DOJ investigation over COVID-19 nursing home deaths and alleged false testimony to Congress, amid ...

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

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

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

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

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 ...

FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad said based on data from tests that measure immune ...