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Advanced Magnetics, Inc.
FDA committee does not recommend approval of molecular imaging agent
April 10th, 2005
Advanced Magnetics, Inc., (AVM) and Cytogen Corporation (CYTO) announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 15 to 4 to not recommend approval of the proposed indication for Combidex, Advanced Magnetics' investigational functional molecular imaging agent. In making its recommendation, the committee cited insufficient clinical data to support a broad indication for use of Combidex to differentiate metastatic from nonmetastatic lymph nodes across all cancer types. A decision by the FDA on Combidex is expected by the FDA-designated user fee goal date of March 30, 2005. ...
Source: Aging & Elder Health Week (2005-04-10)
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