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Sandra Horning

Genentech announces FDA approval of Xofluza (baloxavir marboxil) for influenza

Genentech announces FDA approval of Xofluza (baloxavir marboxil) for influenza

SOUTH SAN FRANCISCO, Calif. — Genentech, a member of the Roche Group  announced that the U.S. Food and Drug Administration (FDA) has approved Xofluza (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. Xofluza is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action

FDA grants priority review to single-dose flu drug

FDA grants priority review to single-dose flu drug

SOUTH SAN FRANCISCO, Calif. — Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The FDA is expected to make a decision on approval by

PP_1170x120_10-25-21