ARTICLE | Clinical News

Xolair omalizumab regulatory update

July 18, 2016 7:00 AM UTC

FDA approved an sBLA from Roche’s Genentech unit for Xolair omalizumab to treat moderate to severe persistent asthma inadequately controlled with inhaled corticosteroids to include patients ages 6-11. The recombinant humanized mAb against IgE is approved in the U.S. in patients ages >=12 for the indication and to treat chronic idiopathic urticaria. ...