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

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

President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could ...

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

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

We want to see vaccines that are available for high-risk individuals, and at the same time, we want some good science,’ FDA ...

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain ...

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of ...

The restrictions on Novavax's vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that ...

A new FDA framework for Covid-19 vaccines created confusion among physicians about what it means for young children ...

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