US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly ...

The Trump administration said it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else.

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit ...

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 ...

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

US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly ...

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

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 agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...