Tags : Nocturnal

Biosimilars Regulatory

Alexion’s Ultomiris (Ravulizumab-Cwvz) Receives FDA Approval in Patients with Paroxysmal

Shots: The approval is based on P-III study results assessing of Ultomiris (IV qw, q8w) vs Soliris in 441 patients who were not treated with inhibitors or Soliris with patiparoxysmal nocturnal hemoglobinuria (PNH) The study demonstrated a non-inferiority data showing biosimilarity of Ultomiris to Soliris q2w with safe and well tolerated profile Ultomiris (ravulizumab-cwvz) is a […]Read More