The vaccine eligibility change is a threat to the health of Americans, some experts say, adding that the FDA is not being forthcoming about its research.

FDA now requires Pfizer and Moderna COVID-19 vaccines to carry expanded warning labels about risks of myocarditis and pericarditis ...

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

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

It began in 2020 with a coordinated push to generate public backlash to lockdowns. The ultimate aim was restoring normalcy, ending a politically and economically inconvenient crisis. Over time, ...

The U.S. Food and Drug Administration will now require COVID-19 vaccines from Pfizer/BioNTech and Moderna to use expanded ...

The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge ...

From my colleague Adam Feuerstein: French drug maker Sanofi is acquiring the small biotech Vigil Neuroscience for $470 ...

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

The FDA's new vaccine guidelines focus on older adults, citing insufficient evidence for the need for additional COVID shots for those under 65.

The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials ...