The FDA recommended different standards of evidence for approval based on patients' risk of getting severely sick from Covid.

FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.

The Food and Drug Administration has outlined new regulations for COVID-19 booster shots, setting stricter approval standards ...

On Tuesday, the Food and Drug Administration announced that Covid booster shots will be limited to people over 65 and those ...

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

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

The Food and Drug Administration will issue new guidelines requiring stiffer clinical trials prior to the approval of new ...

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

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

Top officials in the Trump administration on Tuesday announced they will limit the approval of new COVID-19 vaccines to ...