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 ...

Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and ...

The agency told vaccine makers that COVID-19 vaccines used in the United States starting in fall 2025 should be based on JN.1 ...

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

The data show a continuation of a decades-old trend toward increasing US excess deaths, mainly among working-age adults, ...

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

There were over 1.5 million "missing Americans" in 2022 and 2023, deaths that would have been averted if US mortality rates matched those of peer countries.

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 ...

Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were ...

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 ...