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

Advisers to the FDA will debate if the virus has mutated enough since last winter to require a tweak to the formula.

Despite an explanation of the new strategy published Tuesday from FDA Commissioner Marty Makary and Vinay Prasad, who ...

The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the ...

In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA ...

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, ...

On May 20, 2025, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine.

The U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 ...

Frank DeStefano, MD, MPH, was there when the CDC's Vaccine Safety Datalink (VSD) first came online in 1990, when the agency ...