Where some see a 'rural neighborhood watch' that saves money, others worry about liability and ties to extremism.

Incyte Biosciences Canada today announced that Health Canada has granted a Notice of Compliance for OPZELURA® (ruxolitinib ...

Dietary supplements aren't FDA-approved like drugs. The director of the Office of Dietary Supplements offered advice ...

The FDA De Novo pathway provides a regulatory process for novel medical devices that are found to be low to moderate risk and lack an appropriate predicate device. Acceptance of the company’s De Novo ...

“Receipt of Fast Track designation underscores the urgent need in these patients and our belief that IV Choline Chloride has the potential to serve as the first FDA-approved IV choline therapy ...

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 ...

As AI technology evolves rapidly, the FDA is tackling the challenge of balancing innovation with patient safety, shaping regulations that ensure AI tools remain effective throughout their entire ...

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 ...

Researchers at University of California San Diego School of Medicine found an FDA-approved drug used to treat breast cancer has the potential to be an effective therapeutic for a specific type of ...

The global nanomedicine market is growing rapidly, driven by advances in nanotechnology-based drug delivery and personalized ...