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» Genentech Caught off Guard, FDA Issues Refuse-to-File for T-DM1
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Genentech Caught off Guard, FDA Issues Refuse-to-File for T-DM1
Aug. 30, 2010
By
Catherine Hollingsworth
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The FDA sent a refuse-to-file letter to Genentech Inc., a member of the Roche Group, rejecting the company's application for accelerated approval of trastuzumab-DM1 (T-DM1) and catching investors and the company off guard. (BioWorld Today)
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