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

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 ...

Trump admin's new FDA update limits annual COVID shots to high-risk groups, ending routine access for healthy kids and adults ...

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

The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter ...