(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
Posted in Business, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged adults, allergic reactions, CHILDREN, FDA approval, Levi Garraway, Multiple Foods, Reducing, Roche, Xolair®
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
Posted in Healthcare, Pharma & Biotech, Switzerland
Tagged Chronic Spontaneous Urticaria (CSU), Novartis, Vasant Narasimhan, Xolair®
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
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