The FDA announced that it would only allow COVID-19 vaccinations for those 65 years of age and over and those with certain ...

The agency will require manufacturers to conduct randomized, controlled trials to secure approval for healthy Americans.

Leaders of the Food and Drug Administration May 20 announced new guidelines for administering the COVID-19 vaccine in a paper ...

Federal officials unveiled a rigorous regulatory approach to future COVID vaccines that could make it harder for many people ...

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

The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the ...

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

FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.

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

Large, lengthy studies will be needed for the agency to approve boosters for healthy adults and children, regulators said.

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over ...