The Food and Drug Administration (FDA) has granted Fast Track designations to luspatercept (Celgene and Acceleron) for use in two separate indications: for the treatment of patients with transfusion dependent beta-thalassemia and for the treatment of patients with non-transfusion dependent beta-thalassemia.
The Food and Drug Administration (FDA) has approved Cerus’ Intercept Blood System for plasma and platelets, the first pathogen reduction system to use in preparation of plasma and platelets in order to reduce the risk of transfusion-transmitted infections (TTI).
Octapharma USA announced that Octagam 10% [Immune Globulin Intravenous (Human)] liquid preparation is now available for the treatment of adults with chronic immune thrombocytopenic purpura (ITP).
The Food and Drug Administration (FDA) has granted Fast Track designation to NKTT120 for the treatment of sickle cell disease.
The mammalian target of rapamycin complex (mTORC) pathway seems to be involved in antiphospholipid syndrome-associated vascular lesions.
The FDA has designated Busulipo (MZH-2; Pharmalink) Orphan Drug status for use in cancer patients prior to hematopoietic stem cell transplantation (HSCT).
Researchers found that levels of suppression of tumorigenicity 2 (ST2) were most significantly associated with outcome.
Some patients with antiphospholipid syndrome with non-criteria manifestations may improve after treatment with rituximab.
Adding infliximab to standard intravenous immunoglobulin to reduce inflammation in acute Kawasaki disease is safe in children, even those younger than 1 year, according to a phase 3 randomized trial presented at IDWeek 2012.
The FDA has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra (immune globulin subcutaneous [Human] 20% Liquid, from CSL Behring) from 18 to 24 months.
