FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...

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

Seattle vaccine experts were confused by the country's apparent new direction around updated COVID-19 shots, which top FDA ...

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 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 certain ...

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

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

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

Before being confirmed as the head of the U.S. Food and Drug Administration (FDA) on March 25, Dr. Marty Makary was an ...

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

China continues to be a source of innovation as Pfizer strikes biggest pact yet; HHS provides more info on Trump’s Most Favored Nation executive order; FDA Commissioner Marty Makary and CBER director ...