FDA Alerts

FDA Alert
FDA Alert
05/20/2026
Anthony Calabro, MA
The FDA approved oral decitabine and cedazuridine (Inqovi) tablets with venetoclax for adults with newly diagnosed acute myeloid leukemia who are aged 75 years or older or have comorbidities that preclude...
05/20/2026
FDA Approval
FDA Approval
05/14/2026
Ashton L. Stahl
The FDA has approved sonrotoclax for adults with relapsed or refractory mantle cell lymphoma who have received prior BTK inhibitor therapy.
05/14/2026
FDA Alert
FDA Alert
12/15/2025
Kate Young
An open-label, randomized trial found that daratumumab and hyaluronidase-fihj administered subcutaneously improved the risk of disease progression or death in patients with multiple myeloma. As a result,...
12/15/2025
FDA Alert
FDA Alert
01/09/2025
Anthony Calabro, MA
The FDA has approved concizumab-mtci, a daily subcutaneous treatment to reduce bleeding for patients with hemophilia who have clotting factor inhibitors.
01/09/2025
FDA Alert
FDA Alert
10/25/2024
Miranda Manier, BA
The FDA has approved a novel therapy for patients with hemophilia A or B without inhibitors. Clinical trials showed it significantly reduces bleeding episodes by targeting a new protein in the blood...
10/25/2024
FDA Alert
FDA Alert
10/25/2024
Miranda Manier, BA
The FDA has approved a novel therapy for patients with hemophilia A or B without inhibitors. Clinical trials showed it significantly reduces bleeding episodes by targeting a new protein in the blood...
10/25/2024
FDA Alert
FDA Alert
03/19/2024

Jessica Ganga

Jessica Ganga
The FDA approved two gene therapies, the first of their kind, to treat patients aged 12 years and older with sickle cell disease.
03/19/2024
FDA ALERT
FDA ALERT
01/26/2024
Anthony Calabro, MA
The FDA approved pirtobrutinib for adults with either chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy.
01/26/2024
FDA alert
FDA
FDA alert
02/08/2023
The FDA approves the first-of-its-kind treatment for anemia caused by CKD for adults who receive dialysis following the results of a randomized clinical trial.
02/08/2023
Thrombocytopenia
Thrombocytopenia
02/06/2019
The FDA has approved the first therapy specifically indicated (in combination with plasma exchange and immunosuppressive therapy) for the treatment of adults with acquired thrombotic thrombocytopenic...
02/06/2019