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.

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,

Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit future shots to older Americans and people at higher risk of serious Covid-19 infection.

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration. The company said it would resubmit the application later this year with vaccine efficacy data from a late-stage trial of its experimental seasonal influenza vaccine,

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

Help Register Login Login Hi, %{firstName}% Hi, %{firstName}% Games Car rental The U.S. Food and Drug Administration (FDA) has officially approved a COVID-19 vaccine from Novavax for adults 65 and older and for individuals ages 12 to 64 who have an underlying health condition that puts them at higher risk for serious illness from a coronavirus infection.

The U.S. Department of Health and Human Services is planning to drop recommendations for routine COVID-19 vaccines for pregnant women, teens and children, the Wall Street Journal reported on Thursday,