"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 ...

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

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

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

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

The vaccine, Nuvaxovid, is the third coronavirus shot to gain full approval, joining vaccines from Pfizer and Moderna. It has ...