Cell Therapeutics Files Appeal On FDA Decision On New Drug Application (NDA) For Pixa

tD33NAt

Active member
Mar 24, 2008
12,519
0
36
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced that it has submitted a formal appeal to the Office of New Drugs in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research regarding the agency's decision from earlier this year on the pixantrone New Drug Application ("NDA") to treat relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL"). CTI had requested accelerated approval of its pixantrone NDA for a patient group for which there are no drugs currently approved in this clinical setting...


nvWmrgHoybE


More...
 
Back
Top