FDA News

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.

Early phase 2a study results of a combination of the 2 agents previously evaluated as NASH monotherapies led to the FDA award for Pfizer.

The Labcorp home test, available without a prescription, is delivered overnight and includes a return envelope. Results are available in 1-2 days.

Dupilumab is approved for the treatment of eosinophilic esophagitis in patients aged ≥12 years weighing at least 40 kgs.

Children aged 5 to 11 years can receive a single dose booster shot 5 months after completing a primary 2-dose series of the Pfizer COVID-19 vaccine, FDA says.