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 ...

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

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

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

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

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

The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it ...

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

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

Government advisers are split on whether drugmakers should update their COVID-19 vaccines to better protect Americans this ...