Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

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

The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination ...

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 ...

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

COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a major new policy shift unveiled Tuesday by the Trump administration.

Additionally, the Department of Health and Human Services unveiled the framework for the Most Favored Nation drug pricing ...

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

FDA officials have warned the American public to not eat, sell or serve cucumbers grown and distributed by two Florida ...

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.