Roche Provides Update On FDA Application For T-DM1

[News]

Roche (SIX: RO, ROG; OTCQX: RHHBY) 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 continue with its ongoing Phase III EMILIA registration study...

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