Black box warnings are the FDA’s bluntest regulatory instrument short of a recall. Yet despite what headlines, pundits, and influencers often suggest, they are neither a moral verdict nor the final ...

What do “Black Box” warnings mean on certain medications? Black box warnings, also known as boxed warnings, are the most stringent warnings the FDA can mandate for prescription drugs, alerting health ...

The U.S. Food and Drug Administration is reportedly preparing to place a serious “black box” warning on COVID-19 vaccines, according to a CNN report citing people familiar with the agency’s plans. A ...

Want more stories like this? Subscribe to our new menopause newsletter. Dr. Marty Makary, the commissioner of the Food and Drug Administration (FDA), said in an interview with CNN last week that ...

Osteoporosis drug romosozumab showed no increased risk for the development of cardiovascular (CV) events compared with anabolic osteoporosis drugs, contrary to its black box warning, new research ...