Catalyst Biosciences announced the initiation and open enrollment of the Phase 2 part of its Phase 2/3 program of marzeptacog alfa (activated), a highly potent, subcutaneously administered Factor VIIa therapy in development for the treatment of hemophilia A and B with inhibitors.
The U.S. FDA has accepted for review the New Drug Application for Azedra (iobenguane I 131) to be indicated for patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma.
Novartis announced that its combination therapy Tafinlar (dabrafenib) + Mekinist (trametinib) was granted Priority Review by the U.S. FDA for the adjuvant treatment of stage 3 BRAF V600 mutation-positive melanoma.
This morning, the U.S. FDA granted regular approval to hydroxyurea for the treatment of pediatric patients from 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises.
Pfizer has announced that the U.S. FDA approved a supplemental New Drug Application for Bosulif (bosutinib) to include patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia.