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

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

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

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 ...

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

FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...

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 ...

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 ...