View Single Post
Old 08-27-2010, 04:53 AM   #1
News
Senior Member
 
News's Avatar
 
Join Date: Oct 2007
Posts: 18,957
Genentech receives FDA Refuse to File letter for accelerated approval of trastuzumab-

ImmunoGen, Inc., a biotechnology company that develops antibody-based targeted anticancer products, today announced that Genentech, a member of the Roche Group, today announced its receipt of a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Biologic License Application (BLA) for trastuzumab-DM1, or T-DM1, submitted in July 2010.

More...
News is offline   Reply With Quote