New draft guidelines suggest the FDA is open to exercising regulatory flexibility for non-opioid drugs being developed for chronic pain.

Novocure (NASDAQ: NVCR) today announced it submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Tumor Treating Fields (TTFields) therapy for the ...

Though brain chips are all over TV and the news now with Neuralink, scientists like those at Caltech have been working on the ...

Apple unveils iPhone 17 lineup, new AirPods Pro, and upgraded smartwatches ahead of the holiday shopping season. Newsweek's ...

ONWARD recently announced that the FDA has approved an investigational device exemption (IDE) for the ARC-IM System. This approval allows the initiation of Empower BP, a global pivotal study to assess ...

Advisory committee meetings help FDA scientists make decisions and increase public understanding of drug regulation, and ...

The FDA is moving to scale back its long-standing use of expert panels to review drug applications, KFF Health News reported Sept. 12. George Tidmarsh, MD, PhD, director of the FDA’s Center for Drug ...

Discover how Anthropic's Claude Code Interpreter transforms workflows with AI-powered data analysis, reporting, and ...

Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative ...

Aug. 20 (UPI) --The Food and Drug Administration has authorized emergency use of animal drugs to treat and prevent infestations of the New World Screwworm, which poses an emerging threat to U.S.

After an FDA rejection in May, Stealth BioTherapeutics has resubmitted a new drug application for its investigational treatment designed to treat an ultra-rare genetic disease. This is the biotech’s ...