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

Details of the new rules for COVID-19 vaccine approvals were also outlined in an article published by The New England Journal ...

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

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

The VRBPAC meeting comes the week after the World Health Organization (WHO) recommended that members consider using ...

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...

The rollout of updated COVID vaccines for healthy children and adults is likely to be delayed after the Food and Drug ...

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...

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

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain ...