Top officials for the FDA laid out new requirements limiting access to yearly COVID shots for healthy younger adults and ...

FDA Commissioner Marty Makary and Dr. Vinay Prasad outlined their booster shot clinical trial requirements in the New England Journal of Medicine.

The US Food and Drug Administration (FDA) announced today that it will only recommend COVID-19 vaccines for adults 65 and ...

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...

In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people ...

The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 ...

The U.S. Food and Drug Administration is investigating a salmonella outbreak linked to cucumbers sold in several states, ...

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...