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

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

The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning ...

Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter ...

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be ...

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory ...

Advisers to the Food and Drug Administration met Thursday to help decide which variant of the virus that causes COVID should ...

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

The FDA is forcing Pfizer and Moderna to expand warning labels about the risks of two forms of heart damage, myocarditis and ...

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

The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to receive booster shots. FDA officials are asking for more data around the ...

The FDA has called for Pfizer and Moderna to update the safety information on their mRNA COVID-19 vaccines to include warnings on the incidence of myocarditis and pericarditis, according to two ...