Shots: The US FDA has accepted Novartis’ BLA and has granted Priority Review for crizanlizumab to prevent vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD) The FDA submission […]readmore
Tags : SEG101
Regulatory
Novartis’s SEG101(crizanlizumab) Receives FDA’s Breakthrough Therapy(BT) Designation for Sickle Cell
Shots: The BTD is based on P-II SUSTAIN study results assessing crizanlizumab (5 mg/kg) vs PBO in patients with/without hydroxyurea therapy for preventing vaso-occlusive crises(VOCs) in SCD P-II SUSTAIN study […]readmore