The FDA classified a nationwide recall of chocolate products from Weaver Nut Company as class I -- the highest risk level -- ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines. The Food and Drug Administration announced the update ...

The recall will remain active until the FDA and Carley's Inc. have resolved the labeling issue and ensured that all misbranded products are removed from the market. Consumers who have purchased ...

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously reported, the FDA sent letters to Moderna and Pfizer/BioNTech in April, ...

Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”)[1] for ...

A young Pittsburgh-area police officer died by suicide and pointed to Lasik eye surgery complications as the reason. Now his Penn Hills family is demanding industry accountability.

FDA requires updated warning about rare heart risk with COVID shots Myocarditis emerged as a complication after the first shots became widely available in 2021.