FDA Alerts

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
sickle cell disease
sickle cell disease
08/09/2018
Shaina M. Willen, MD, pediatric hematologist at the Vanderbilt University Medical Center, discusses the recent FDA approval of L-glutamine oral powder for sickle cell disease - the first FDA-approved...
08/09/2018
sickle cell disease
sickle cell disease
08/03/2018
Shaina M. Willen, MD, pediatric hematologist at the Vanderbilt University Medical Center, discusses the recent FDA approval of L-glutamine oral powder for sickle cell disease - the first FDA-approved...
08/03/2018