Panel members had questions about whether a new FDA proposal to require randomized trials for vaccines in healthy adults ...

Senior Biden Food and Drug Administration (FDA) officials spent weeks casting doubt on reports of cardiac risks associated ...

The FDA has ordered Pfizer and Moderna to amend the warning labels on their COVID-19 vaccines with risk of myocarditis and pericarditis.

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

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

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

The US Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines. The updated warnings highlight a rare risk of heart inflammation in ...

The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart ...