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FDA fast tracks Bracco’s BR55 for Crohn’s disease bowel inflammation detection

The company is currently preparing for Phase III trials to further assess the efficacy and safety of the agent in identifying active inflammation in individuals with Crohn's disease. Credit: ...
Yahoo Finance

Bracco Imaging Receives FDA Fast Track Designation for BR55, Ultrasound Molecular Imaging Agent for the Detection of Active Bowel Inflammation in Crohn's Disease

BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the detection of active bowel ...
Monthly Prescribing Reference

VEGFR2-Binding Contrast Agent Fast Tracked for Crohn Disease Assessment

BR55 was safe and highly accurate (>95%) at marking VEGFR2 expression in patients with breast, ovarian and thyroid cancer, as well as Crohn disease. The Food and Drug Administration (FDA) has granted ...
ascopubs.org

Ultrasound Molecular Imaging With BR55 in Patients With Breast and Ovarian Lesions: First-in-Human Results

Phase II Study of the Efficacy and Safety of Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma USMI with MB KDR was well tolerated by all patients without safety concerns. Among the 40 ...
GlobalData on MSN

FDA fast tracks Bracco’s BR55 for Crohn’s disease bowel inflammation detection

The US Food and Drug Administration (FDA) has granted fast track designation for the development of Bracco Imaging's ...