American Society of Hematology

FDA Alerts

In collaboration with the Food and Drug Administration (FDA), and as a service to our members, ASH provides information about newly approved therapies and other important FDA actions (e.g., updated safety information, new prescribing information) for patients. This allows the agency to inform hematologists and professionals in hematology-related fields of recent approvals in a timely manner. In providing this information, ASH does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.
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  • FDA Approves Dalteparin Sodium for VTE in Pediatric Patients May 17, 2019

    The Food and Drug Administration approved dalteparin sodium (FRAGMIN, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older.

  • FDA Approves Venetoclax for CLL and SLL May 16, 2019

    The Food and Drug Administration approved venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

  • Ivosidenib Approved as First-Line Treatment for AML with IDH1 Mutation May 03, 2019

    The Food and Drug Administration approved ivosidenib (TIBSOVO, Agios Pharmaceuticals, Inc.) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.

  • FDA Warns About the Risks Associated with the Investigational use of Venclexta in Multiple Myeloma Mar 25, 2019

    The Food and Drug Administration is alerting health care professionals, oncology clinical investigators and patients about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma based on data from a clinical trial. Venclexta is not approved for the treatment of multiple myeloma.

  • FDA Approves Caplacizumab-yhdp Feb 06, 2019

    The Food and Drug Administration approved caplacizumab-yhdp (CABLIVI, Ablynx NV) for adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

  • FDA Approves Ravulizumab-cwvz for Paroxysmal Nocturnal Hemoglobinuria Jan 08, 2019

    The Food and Drug Administration approved ravulizumab-cwvz (ULTOMIRIS, Alexion Pharmaceuticals, Inc.) for adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

  • FDA Approves Longer-Acting Calaspargase Pegol-mknl for ALL Dec 20, 2018

    The Food and Drug Administration approved calaspargase pegol-mknl (ASPARLAS, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years.

  • FDA Approves Romiplostim for Pediatric Patients With ITP Dec 14, 2018

    The Food and Drug Administration approved romiplostim (NPLATE, Amgen Inc.) for pediatric patients 1 year of age and older with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

  • FDA Approves Biosimilar Truxima for Non-Hodgkin Lymphoma Nov 28, 2018

    The Food and Drug Administration approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

  • FDA Approves Gilteritinib for Relapsed or Refractory AML With FLT3 Mutation Nov 28, 2018

    The Food and Drug Administration approved gilteritinib (XOSPATA, Astellas Pharma US Inc.) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

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