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

The agency is changing the standard of evidence required for Covid-19 vaccine approval in the US, Dr. Vinay Prasad, the new ...

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

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

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

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

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

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

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

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

The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it ...