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

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

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

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

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

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

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

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

Nearly 4,500 cases were pulled from shelves in 23 states after it was found that the affected cans had been mislabeled.

Novavax had expected full approval for broader use by April 1, after the FDA reviewed data from a 30,000-person clinical ...

The U.S. Food and Drug Administration approved Novavax's COVIDd-19 vaccine with age restrictions after a six-week delay.