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

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 ...

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.

Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were instrumental in saving lives during the COVID pandemic.

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 ...

The vaccine is expected to remain available for anyone who is at least 65 or who has a medical condition, leaving many Americans ineligible. Here's what we know.

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.