Roche provides update on FDA application for T-DM1
Roche provides update on FDA application for T-DM1
Roche expects a global regulatory submission mid 2012. Roche today announced that the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company’s trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). As planned Roche will…
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Categories: Breast Cancer Tumor Tags: application, Provides, Roche, TDM1, Update