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

The FDA picked the LP.8.1 Covid strain for the fall vaccines, fueling concerns that the shots may be limited to only the most ...

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

In a major and controversial policy shift, the FDA announced in a New England Journal of Medicine article that updated ...

FDA's new COVID-19 vaccine policy may restrict low-risk individuals' access, pending clinical trials to prove benefits.

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

On May 22, an FDA advisory committee unanimously recommended COVID-19 vaccine manufacturers target the JN.1 variant in their formulations.  The Vaccines and Related Biological Products Advisory ...

Elaine Chen covers biotech, co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud.

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

Despite the fact that vaccines against COVID have already undergone strict safety reviews and that people continue to die ...

Vaccine opponents and skeptics in charge of federal health agencies are restricting access to COVID shots that were a signature accomplishment of President Donald Trump’s first term.

The Trump administration released a 72-page report Thursday outlining its take on what's driving "a chronic disease crisis" ...