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 ...

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

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

Novavax shares jumped more than 15% on Monday after the company secured a long-awaited U.S. regulatory approval for its COVID ...

Top officials for the Food and Drug Administration laid out new requirements for yearly updates to COVID shots, saying they'd ...

The agency will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...

COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a major new policy shift ...

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of ...

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

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

Regulators will soon “unleash a massive framework” for how vaccines are tested and approved, according to FDA Commissioner ...