If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...

Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...

Moderna is deprioritizing its flu/COVID combination vaccine in younger adults amid a push to cut about $1.5 billion from its ...

“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...

The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...

Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine.

A clinical trial is underway to assess the effectiveness and safety of sipavibart, AstraZeneca's long-acting monoclonal antibody designed to provide protection against Covid-19, as a potential ...

At the peak of the COVID-19 pandemic, many vaccine skeptics turned to ivermectin, a medication proven to fight off parasitic ...

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

The Food and Drug Administration was set to release new guidance on COVID booster shots ahead of the fall season, but that's ...

Novavax's COVID vaccine was approved under an emergency use authorization in August 2022, and the company has pursued full ...