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

I'm a clinical academic, which is quite a rare breed of doctor, because what I'm doing, along with other clinical academics, ...

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

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

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

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.

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.

The question was asked by Capt. Sarah Meyer, a pediatric vaccine expert with the Centers for Disease Control and Prevention and member of the committee, the Vaccines and Related Biological Products ...

Historically, almost everyone has been eligible for Covid vaccines; the C.D.C. recommended the most recent vaccine for all ...