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.
Hematologic Disorders
First Treatment for Newly Diagnosed Light Chain Amyloidosis Approved
The approval was based on data from the open-label, active-controlled phase 3 ANDROMEDA study.
Sitagliptin Promising Addition for Preventing Acute GVHD
Low incidence of grade II to IV acute GVHD seen in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation
FDA Requests Clarification of Data to Complete Roxadustat Review
The Agency announced that additional clarification of clinical data was needed prior to completing the review.
IV Iron Products: Adverse Events, Associated Costs Compared
The comparative study aimed to analyze AEs as well as estimate the associated medical costs for 4 IV iron preparations.
Orladeyo Now Available for Hereditary Angioedema
The oral, once-daily treatment will be shipped to patients with a prescription by specialty pharmacy Optime Care, Inc.
FDA Approves Orladeyo to Prevent Hereditary Angioedema Attacks
Orladeyo works by binding to plasma kallikrein and inhibiting its proteolytic activity.
FDA: Risk of Inadvertent Intrathecal Administration of Tranexamic Acid Injection
The FDA has received reports of tranexamic acid injection being erroneously administered intrathecally in the perioperative setting instead of the intended intrathecal anesthetic (eg, bupivacaine injection) for neuraxial anesthesia.
Rilzabrutinib Fast Tracked for Immune Thrombocytopenia
Rilzabrutinib has been granted Fast Track designation for the treatment of immune thrombocytopenia.
Pegcetacoplan Gets Priority Review for Paroxysmal Nocturnal Hemoglobinuria
Pegcetacoplan is a synthetic cyclic peptide conjugated to a polyethylene glycol polymer that inhibits the complement cascade centrally at C3 and C3b.
