A food recall of nearly 6,000 cases of cookies distributed across 15 states has been given the U.S. Food and Drug ...

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously ...

Labels for the Pfizer and Moderna shots, which already caution about myocarditis and pericarditis, will more strongly stress ...

Writing in JAMA, four former governmental officials warn that the Trump administration’s involvement in delaying the approval ...

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines ...

Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the ...

Several ready-to-eat chicken fettuccine alfredo meals sold at Kroger and Walmart are being voluntarily recalled due to a ...

The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver ...

AG Kris Mayes urges FDA to address heavy metals in baby food, echoing a coalition of state attorneys' concerns.

Supermarket chain Hy-Vee issued a voluntary recall for a range of sushi products on June 5 for possible listeria contamination.

The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne ...

In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...