The US Food and Drug Administration has approved Roche/Shionogi & Co’s Xofluza for the treatment of acute uncomplicated flu, opening the door to the first new antiviral with a novel mechanism of action in nearly 20 years.
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Roche has unveiled late-stage data showing that its experimental antivrial drug baloxavir marboxil hit efficacy and safety targets in patients with flu.
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The US Food and Drug Administration will undertake a priority review of Genentech’s experimental flu drug baloxavir marboxil in people aged 12 years and older.
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