• FDA grants priority review to novel flu antiviral

    19 days ago - By Healio

    Genentech announced that the FDA has accepted a new drug application and granted priority review for the company's single-dose, oral influenza treatment baloxavir marboxil.
    The investigational medication is designed to inhibit the cap-dependent endonuclease protein crucial for influenza virus replication, including in oseltamivir-resistant and avian strains, according to a news release. It is intended for patients aged 12 years and older with acute, uncomplicated influenza.
    Genentech said the FDA is expected to make a decision on the approval of baloxavir marboxil by Dec. 24. If approved,
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