The U.S. Food and Drug Administration has issued a recall of glucose monitors used by those with diabetes for malfunctioning.

The application is based on data from multiple subcutaneous (SC) administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension (OLE), following the 18-month ...

Studies in the early 2000s claimed there were major risks associated with HRT. The Food and Drug Administration said Monday it will remove the "black box" warning from hormone replacement therapy (HRT ...

Royal Philips received a letter from the Food and Drug Administration warning that some of the medical device maker's facilities don't comply with federal manufacturing regulations. The warning letter ...

Having exhibited her proficiency through diverse and complex characters, Sydney Sweeney has established herself as a high-profile Hollywood actress. With Sweeney’s value in the entertainment industry ...

Tylenol maker Kenvue is calling on the Food and Drug Administration (FDA) to back off a proposed safety label change to acetaminophen after the Trump administration linked its use during pregnancy to ...

Please provide your email address to receive an email when new articles are posted on . Drug-coated devices did not improve amputation rates vs. uncoated devices in patients with limb-threatening ...

The FDA last overhauled its Nutrition Facts label in 2016. Now, a decade later, new food and beverage label changes are expected to roll out. What’s on your label? It may be changing soon. The Food ...

The Food and Drug Administration is requesting public comment to get feedback on current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real ...

With a government shutdown now in effect, the U.S. FDA—already shaken up by head count reductions earlier this year—has sought to keep many of its functions running for the foreseeable future. But the ...

Medication abortion is used in nearly two-thirds of abortions in the U.S. Health and Human Services Secretary Robert F. Kennedy Jr. told Republican states this week that the FDA would conduct a new ...