This is a discussion on Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair) within the FDA News forum, part of the Industry News and Updates category; FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests an increased number of cardiovascular ...
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FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests an increased number of cardiovascular and cerebrovascular adverse events in a group of patients using Xolair compared to a group of patients not given the drug (control group).
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