The framework the new FDA leaders laid out on Tuesday raised small and big questions about the regulatory process, vaccine ...

The hearing was supposed to focus on the Trump administration’s 2026 budget request, but instead covered a wide range of ...

The Food and Drug Administration (FDA) will require more evidence for what top officials describe as the uniquely American ...

Healthy and under the age of 65? You might not need to receive an annual COVID-19 booster. What to know about new guidelines.

Seven weeks into his job as FDA commissioner, Marty Makary, MD, MPH, held his own answering a barrage of sometimes ...

"With the COVID pandemic behind us, it is time to adopt a common-sense approach to COVID policy," a spokesperson for the FDA ...

The FDA may limit annual COVID-19 boosters to high-risk groups unless clinical trials prove benefits for healthy adults under ...

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels ...

Food and Drug Administration Commissioner Marty Makary promised stakeholders last week that the agency’s new Covid-19 vaccine ...

We have to admit to ourselves that America is deeply divided on the policy issue of repeat COVID-19 vaccine doses or boosters ...

US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly ...

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen ...