Tag Archives: Xolair®

Roche’s Xolair Nears FDA Approval for Reducing Allergic Reactions to Multiple Foods

(IN BRIEF) Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) under Priority Review. The sBLA is for the reduction of allergic reactions, including anaphylaxis, caused by … Read the full press release

Novartis: Xolair helps patients with Chronic Spontaneous Urticaria (CSU) achieve significant improvements in quality of life measures

New analysis from pivotal Phase III studies show Xolair® (omalizumab) significantly improved quality of life scores for Chronic Spontaneous Urticaria (CSU) patients compared to placebo[1],[2] Additional data at WCD show the consistent negative health impact and economic burden of CSU, … Read the full press release

Novartis’s omalizumab met all primary and secondary endpoints in pivotal GLACIAL study of patients with severe form of chronic skin disease CSU

Omalizumab met all primary and secondary endpoints in pivotal GLACIAL study of patients with refractory chronic spontaneous urticaria (CSU)[1] Omalizumab found to be effective, safe and well tolerated in refractory CSU patients, including those on antihistamines at up to four … Read the full press release