Spontaneous Urticaria

• CLINICAL_TRIALS trial_result · 2016-08-19
  Clinical Trial Update: High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria [Phase 3]

  An update on a Phase 3 trial evaluating high-dose vitamin D supplementation for chronic spontaneous urticaria, sponsored by Shiraz Universit…

• FDA label_change · 2016-07-06
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) to update its labeling.

• CLINICAL_TRIALS research · 2015-07-28
  Clinical Trial Update: Profiling Urticaria for the Identification of Subtypes

  Clinical trial update profiling subtypes of chronic spontaneous urticaria (non-autoreactive, autoimmune, and autoreactive/non-autoimmune) to…

• FDA label_change · 2014-09-26
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) submitted by Genentech, resulting in a label change/indication update for th…

• CLINICAL_TRIALS trial_result · 2014-04-15
  Clinical Trial Update: Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients [Phase 2, Phase 3]

  Prospective double-blind, placebo-controlled trial of omalizumab (Xolair) in chronic urticaria, spanning Phase 2 and Phase 3 cohorts.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA label_change · 2014-02-14
  FDA Approved: XYZAL — Supplemental Application (Chattem, Inc.)

  FDA has received a supplemental application for XYZAL (levocetirizine dihydrochloride) from Chattem, Inc.

• CLINICAL_TRIALS trial_result · 2013-10-18
  Clinical Trial Update: A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment [Phase 3]

  A Phase 3 trial evaluating the efficacy and safety of omalizumab (Xolair) in chronic idiopathic urticaria and chronic spontaneous urticaria …

• CLINICAL_TRIALS trial_result · 2013-09-02
  Clinical Trial Update: A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1) [Phase 3]

  Phase 3 trial evaluating the efficacy, duration of response, and safety of Xolair (omalizumab) in patients with chronic idiopathic urticaria…

• FDA approval · 2010-12-21
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) submitted by Genentech, Inc., resulting in updated labeling.

• FDA approval · 2010-01-04
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved Genentech's supplemental application for XOLAIR (omalizumab), updating its labeling via a supplemental approval.

• FDA approval · 2007-07-02
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) from Genentech, Inc., to modify/expand its labeling.