Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...

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

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

The U.S. FDA is planning to require all new vaccines to undergo placebo-controlled trials before approval. Read more here.

The agency suggested that clinical trials in humans may be required for updated Covid shots, raising questions about whether ...

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine is sowing uncertainty about other ...

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

Kennedy and FDA Commissioner Marty Makary’s approach to assessing vaccines could put Covid boosters out of reach.

The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...

The Department of Health and Human Services said it is redirecting funding from what it calls a wasteful Biden-era project on ...

U.S. health secretary Robert F. Kennedy Jr. reprised various misleading claims about vaccines this week, including that the ...

In an exclusive interview with physician and writer Dr. Jeremy Faust on Substack, Makary opened up about his first weeks on ...