sabato, 5 dicembre 2020
2 Marzo 2018

FDA Accepts BLA for Calaspargase Pegol in Acute Lymphoblastic Leukemia

March 1, 2018 – On February 28, Shire announced that the U.S. Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for calaspargase pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multiagent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target … (leggi tutto)