The FDA has accepted Genentech's application to market Xolair, or omalizumab, as an injectable treatment for chronic idiopathic urticaria in patients who remained symptomatic despite getting antihistamine therapy. The application was primarily based on data from two late-stage trials. A decision is expected by the second quarter of 2014.
FDA to review Genentech's Xolair for chronic idiopathic urticaria
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