Narsoplimab Under Review for Stem Cell Transplant-Associated Thrombotic Microangiopathy
The FDA has accepted for filing and granted Priority Review to narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
The FDA has accepted for filing and granted Priority Review to narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
The approval was based on data from the open-label, active-controlled phase 3 ANDROMEDA study.
Low incidence of grade II to IV acute GVHD seen in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation
The Agency announced that additional clarification of clinical data was needed prior to completing the review.
The comparative study aimed to analyze AEs as well as estimate the associated medical costs for 4 IV iron preparations.
The oral, once-daily treatment will be shipped to patients with a prescription by specialty pharmacy Optime Care, Inc.
Orladeyo works by binding to plasma kallikrein and inhibiting its proteolytic activity.
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Rilzabrutinib has been granted Fast Track designation for the treatment of immune thrombocytopenia.
Pegcetacoplan is a synthetic cyclic peptide conjugated to a polyethylene glycol polymer that inhibits the complement cascade centrally at C3 and C3b.