A new year is upon us, and FDA Commissioner Marty Makary is still staring down many of the same challenges that faced his ...

Torous noted that over the summer, a company called WHOOP received an FDA warning letter over a product that could measure ...

Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App: a strategic ...

The Naox Link system uses soft, biocompatible in-ear electrodes integrated into wired earbuds to acquire, record, and ...

MoonLake regains momentum after the FDA Type B meeting allows BLA submission for sonelokimab in HS without additional trials.

Aurora Therapeutics, cofounded by Nobel Prize–winning scientist Jennifer Doudna, plans to use gene editing and a new FDA ...

Cold and flu medications are among around 2,000 products being recalled by the U.S. Food & Drug Administration over rat feces ...

The FDA has approved a blood test to help diagnose Alzheimer's disease, and doctors explain how it works and why it can lead ...

Aquestive Therapeutics (AQST) stock plunges as FDA flags deficiencies in the company's new drug application for its allergy ...

Officials with the FDA have approved the first generic robenacoxib tablets for the control of postoperative pain and ...

Qure N.V. (NASDAQ:QURE) shares are popping on Friday after the company said the FDA will review the data package for AMT‑130, ...

Hetlioz (tasimelteon) has been approved in the US for a few years to treat sleep disorders affecting people who are blind or ...