AMAG gains positive CHMP opinion for ferumoxytol approval
The intravenous (IV) iron therapy, indicated for the treatment of IDA in adult patients with chronic kidney disease (CKD), will be marketed as Rienso in the European Union
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted priority medicines (PRIME) designation to AbelZeta Pharma’s C-CAR168.
The recommendation by the CHMP of the EMA for approval of ruxolitinib to treat of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis