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 ...

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 ...

Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after ...

Moderna voluntarily pressed pause on its request to license its vaccine candidate, mRNA-1083 — which combines vaccines for seasonal influenza and covid and is intended for people over 50 — until it ...

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

Since 2023, federal health officials have recommended an annual COVID-19 shot for most people, and vaccine makers have not ...

The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from ...

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

The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at ...