The agency is changing the standard of evidence required for Covid-19 vaccine approval in the US, Dr. Vinay Prasad, the new ...

A vaccine that helps people overcome cocaine addiction has shown signs of being safe and effective in a small trial ...

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

The FDA recommended different standards of evidence for approval based on patients' risk of getting severely sick from Covid.

Proposed changes to the vaccine approval process violate ethical and scientific principles.

Late-stage trial data suggest that a new COVID-flu vaccine offers good protection against both infections, but experts expect ...

The vaccine, Nuvaxovid, is the third coronavirus shot to gain full approval, joining vaccines from Pfizer and Moderna. It has ...

WASHINGTON (AP) — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by ...

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

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...

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

WHO members on Tuesday adopted a treaty that outlines how to prepare for and respond to pandemics. One country missing: the U ...