A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels ...

CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an ...

The framework the new FDA leaders laid out on Tuesday raised small and big questions about the regulatory process, vaccine ...

Here’s how COVID-19 vaccine guidance is changing in the U.S. For people at high risk of severe COVID-19. The process of ...

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...

The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to ...

The Food and Drug Administration is adjusting the standard of evidence needed for shots to be approved by the general public.

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk ...

The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the ...