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Tagged With "Xolair"

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FDA Will Consider Xolair for the Treatment of Nasal Polyps

AAFA Community Services ·
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids.
Blog Post

FDA Accepts Biologics License Application for Xolair® Prefilled Syringe for Self-Administration

AAFA Community Services ·
Novartis today announced that the US Food and Drug Administration (FDA) accepted the company's supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved US indications. If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers.
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