On Oct. 24, 2018, the U.S. Food and Drug Administration (FDA) announced it had granted approval of Xofluza (baloxavir marboxil) to Shionogi & Co. for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

This was the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years.