The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

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

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

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

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

Top officials in the Trump administration on Tuesday announced they will limit the approval of new COVID-19 vaccines to ...

But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval of Covid-19 ...

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

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

LOOKING INTO VAX CRYSTAL BALL — The Covid-19 vaccine framework that FDA Commissioner Marty Makary teased last week is expected to drop today, two people familiar with the plan and granted ...

U.S. regulators will no longer approve COVID booster shots for healthy adults and children without new studies, adding a ...