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 Voxelotor for Sickle Cell Disease Nov 26, 2019

    The Food and Drug Administration granted accelerated approval to voxelotor (Oxbryta, Global Blood Therapeutics) for adults and pediatric patients 12 years of age and older with sickle cell disease.

  • FDA Approves Acalabrutinib for CLL and SLL Nov 21, 2019

    The Food and Drug Administration approved acalabrutinib (CALQUENCE, AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

  • FDA Approves Givosiran for Acute Hepatic Porphyria Nov 20, 2019

    The Food and Drug Administration approved givosiran (GIVLAARI, Alnylam Pharmaceuticals, Inc.) for adults with acute hepatic porphyria (AHP).

  • FDA Approves Crizanlizumab-tmca for Sickle Cell Disease Nov 18, 2019

    The Food and Drug Administration approved crizanlizumab-tmca (ADAKVEO, Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.

  • FDA Grants Accelerated Approval to Zanubrutinib for Mantle Cell Lymphoma Nov 15, 2019

    The Food and Drug Administration granted accelerated approval to zanubrutinib (BRUKINSA, BeiGene, Ltd.) for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

  • FDA Approves Luspatercept-aamt for Anemia in Patients with Beta Thalassemia Nov 08, 2019

    The Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corp.) for treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.

  • FDA Approves Daratumumab for Transplant-Eligible Multiple Myeloma Sep 26, 2019

    The Food and Drug Administration approved daratumumab (DARZALEX, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT).

  • FDA Approves Fedratinib for Myelofibrosis Aug 16, 2019

    The Food and Drug Administration approved fedratinib (INREBIC, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

  • Ruxience Approved for the Treatment of Adult Patients with Non-Hodgkin Lymphoma Jul 24, 2019

    The U.S. Food and Drug Administration (FDA) approved Ruxience (rituximab-pvvr), a biosimilar to U.S.-licensed Rituxan (rituximab) for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL) to be used as a single agent or in combination with chemotherapy, and CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with chemotherapy.

  • FDA Grants Accelerated Approval to Selinexor for Multiple Myeloma Jul 03, 2019

    The Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

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