FDA News

The FDA recommended on Thursday the inclusion of a SARS-CoV-2 Omicron component in COVID-19 vaccine booster doses.

If the atogepant label is expanded, the drug will be the only gepant approved for the broad indication of prevention of both episodic and chronic migraine.

The new approval for risankizumab makes it the only interleukin-23 inhibitor for moderately to severely active Crohn disease, according to AbbVie.

The FDA ban yesterday on Juul vaping devices and nicotine e-liquid pods drew praise from the American Medical Association, American Thoracic Society, American Lung Association, among others.

The FDA today denied Juul Labs' premarket tobacco product applications and ordered all products removed from shelves nationwide, ending a 2-year review.

A cap on nicotine levels in cigarettes and other combustible tobacco products may be enforced sooner rather than later.

The FDA authorized emergency use of Moderna and Pfizer-BioNTech's COVID-19 vaccines for use in children as young as 6 months old.

Apple recently announced a new software release that will allow Apple Watch users access to health care-focused features and apps.

If EUA is granted, the Novavax COVID-19 vaccine would be the first protein-based COVID-19 vaccine available in the US.

The Abbott FreeStyle Libre 3 is the smallest, thinnest, and most accurate 14-day CGM with a 7.9% MARD, the company says.