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

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.

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

Here’s how COVID-19 vaccine guidance is changing in the U.S. For people at high risk of severe COVID-19. The process of ...

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 ...

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 ...

The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to ...

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

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

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