FDA Commissioner Marty Makary was met with a skeptical set of Senate appropriators Thursday when he testified on his agency’s ...

The notice came shortly after an advisory panel meeting at which members debated the pros and cons of asking manufacturers to ...

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

CRISPR Therapeutics announced an agreement with Sirius Therapeutics to develop and commercialize small interfering RNA (siRNA ...

Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter ...

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory ...

U.S. Food and Drug Administration advisers unanimously recommended on Thursday that COVID-19 vaccines for the 2025-26 period ...

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.

An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 ...

It may not be the mythical fountain of youth, but the strength of the body's immune system, or immune resilience, could hold ...