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

The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk ...

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

The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination ...

Novavax's shot is now fully approved in the U.S. Since 2022, the vaccine has been used under an emergency use authorization.

In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people ...

COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a major new policy shift unveiled Tuesday by the Trump administration.

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

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

FDA officials have warned the American public to not eat, sell or serve cucumbers grown and distributed by two Florida ...

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 approvals in ...