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

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

FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad said based on data from tests that measure immune ...

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.

Advisers to the U.S. Food and Drug Administration will discuss whether to recommend COVID-19 vaccines for 2025-26 for ...

The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it ...

China on Sunday announced anti-dumping duties as high as 74.9% on imports of POM copolymers, a type of engineering plastic, ...

Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to ...

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

Any new Covid vaccines for many children and adults will be required to undergo randomized, controlled trials before ...

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