Priority Review for Amgen's blinatumomab BiTE

FDA accepted and granted Priority Review to a BLA for blinatumomab ( AMG 103) from Amgen Inc. (NASDAQ:AMGN) to treat adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). The PDUFA date is May 19, 2015. Amgen also submitted an MAA to EMA in the indication. ...