Added by Peter Hofland, PhD on August 31, 2010 at 6:00am — No Comments
Earlier today the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the Roche's trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). However, as planned, Roche will continue with its ongoing Phase III EMILIA registration study. Furthermore, Roche will continue to work with the FDA and expects a global regulatory submission of T-DM1 mid 2012.
T-DM1 is an antibody-drug conjugate (ADC), also known as an armed antibody,…
ContinueAdded by Peter Hofland, PhD on August 27, 2010 at 9:30am — No Comments
Added by Peter Hofland, PhD on August 26, 2010 at 6:30am — No Comments
Added by Peter Hofland, PhD on August 20, 2010 at 6:30am — No Comments
Added by Peter Hofland, PhD on August 13, 2010 at 11:30am — No Comments
Added by Peter Hofland, PhD on August 5, 2010 at 9:30am — No Comments
Added by Peter Hofland, PhD on August 4, 2010 at 10:00am — No Comments
2013
2012
2011
2010
2009
2008
2007
2005
2004
2001
© 2013 Created by Peter Hofland, PhD.
