خبر طازه
Genta: FDA extends review period for Genasense New Drug Application in chronic lymphocytic leukemia (0.88 ) : Co announces that the FDA has notified the co that it has extended the review period for the currently pending NDA for Genasense Injection plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia. Genta has requested a meeting with FDA, and the co has submitted additional data analyses in support of the application. The FDA has indicated that submission of the new information comprises a major amendment to the NDA and has elected to extend the review period for 90 days to January 29, 2007.