Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like irregular heart rhythm or sleep apnea alerts. They are usually labeled as such.

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...

The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo ...

“In accordance with this direction, FDA is delaying the effective date of the final rule ‘Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”’ (89 FR 106064), until ...

There’s too much news and too little context. At Vox, we do things differently. We focus on helping you understand what matters. We don’t obsess over being the first to break news. We focus on ...

Having a tough time reading those food labels? And what constitutes healthy, and can you believe what manufacturers say on a package? The U.S. Food and Drug Administration is trying to help.

The FDA has announced new labeling changes for all testosterone products following a review of clinical trial data, including a TRAVERSE study and postmarket ambulatory blood pressure studies.

Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...

These labels are important ... information that could potentially lead to hazardous administration of the drug and an adverse reaction. This scenario was most notable on the label "Do not chew ...

Results from the open-label extension of its Phase 2 SPRING ... and alignment with FDA on the design of a single Phase 3 registration study for its lead product candidate nebokitug (CM-101 ...

The TRAVERSE trial, a large-scale clinical study with over 5,000 patients, published in 2023, concluded that TRT does not increase the risk of adverse cardiovascular outcomes in men with hypogonadism.