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

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

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

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

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.

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

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

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

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 is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.

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

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