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

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

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

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit ...

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

Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula, targeting the SARS-CoV-2 ...

An FDA committee on Thursday recommended that COVID-19 vaccines for the 2025-2026 respiratory virus season — which, for the ...

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

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

COVID-19 vaccine recommendations could be changing, according to the U.S. Food and Drug Administration. FDA leaders said on May 20 that clinical trials will be required to approve annual COVID-19 ...

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

The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.