The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Novartis’ Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous ...
Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has accepted and filed the company's supplemental biologics license application (sBLA) for subcutaneous use of Xolair (omalizumab) in ...