07:00 , Aug 17, 2009 |  BioCentury  |  Regulation

DaT's good enough

By backing DaTSCAN ioflupane I123 injection from GE Healthcare last week, an FDA panel indicated that a molecular imaging agent that allows physicians to see abnormal changes in the brain has clinical value, and that...
07:00 , Apr 13, 2009 |  BC Week In Review  |  Clinical News

AdreView: Phase III data

Data from 964 patients in ADMIRE-HF, a combination of the identical U.S. and European Phase III MBG311 and MBG312 studies, showed that a high heart to mediastinum ratio (H/M) as measured by imaging with AdreView...
07:00 , Sep 22, 2008 |  BC Week In Review  |  Clinical News

AdreView regulatory update

FDA approved an NDA from General Electric's GE Healthcare unit for AdreView as a molecular imaging agent to detect neuroendocrine tumors. The company plans to launch the iobenguane I 123 injection, which has Orphan Drug...
02:05 , Sep 20, 2008 |  BC Extra  |  Company News

FDA approves GE's AdreView

FDA approved an NDA from General Electric (NYSE:GE) for AdreView as a molecular imaging agent to detect neuroendocrine tumors. The company plans to launch the iobenguane I 123 injection, which has Orphan Drug status in...
07:00 , Jun 16, 2008 |  BC Week In Review  |  Clinical News

AdreView regulatory update

General Electric's GE Healthcare unit said FDA accepted and granted Priority Review to an NDA for AdreView as a molecular imaging agent to detect neuroendocrine tumors. The company expects a decision within 6 months from...