An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 ...

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

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 ...

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

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

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

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...

NEW YORK (Reuters) -The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for ...

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

Moderna had designs on releasing a combined influenza and covid-19 vaccine after some promising trials, but this week the ...