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

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

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 ...

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

Shares of Moderna MRNA declined nearly 8% yesterday after it announced that it had voluntarily withdrawn a regulatory filing ...

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

Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after ...

SWEATING THE MAHA REPORT — A report expected today from Robert F. Kennedy Jr. on childhood chronic diseases could spark ...

FDA COVID vaccine update is stirring major public attention as a new policy limits fall COVID-19 booster shots to seniors and ...

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