Tag Archives: blood disorders

August, 2018

April, 2018

  • 12 April

    FDA Lifts Clinical Hold on US Studies of Bellicum’s BPX-501

    HOUSTON, April 11, 2018 (GLOBE NEWSWIRE) — Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today announced that the U.S. Food and Drug Administration has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments …

January, 2018

November, 2017

  • 27 November

    FDA Updates Label for Alprolix, Adding Long-Term Safety and Efficacy Data

    WALTHAM, Mass.–(BUSINESS WIRE)–Bioverativ Inc. (NASDAQ: BIVV), a global biopharmaceutical company dedicated to transforming the lives of people with rare blood disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the leading extended half-life therapy for the …

August, 2017

January, 2017

  • 9 January

    FDA Grants Orphan Drug Designation To Alexion’s ALXN1210 For PNH

    NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to ALXN1210, a highly innovative, longer-acting anti-C5 antibody that inhibits terminal complement, which is being evaluated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH …

November, 2016

August, 2016

  • 9 August

    Biogen to Name its Hemophilia Drug Spinoff Bioverativ

    CAMBRIDGE, Mass.–(BUSINESS WIRE)–Biogen (NASDAQ: BIIB) today announced that Bioverativ will be the name of the standalone, publicly-traded global biotechnology company that it expects to launch in early 2017. Bioverativ will be focused on the discovery, research, development and commercialization of treatments for hemophilia and other blood disorders. Following completion of …

May, 2015