Mepolizumab Gets Priority Review for Hypereosinophilic Syndrome
The FDA previously granted Fast Track and Orphan Drug designations to mepolizumab for the treatment of HES.
Hematologic Disorders
Ferriprox Twice-a-Day Tablet Dosing Approved for Transfusional Iron Overload Due to Thalassemia Syndromes
The FDA has approved a twice-a-day formulation of Ferriprox® (deferiprone; Chiesi) for the treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.
Sutimlimab Under Review for Hemolysis in Cold Agglutinin Disease
The FDA has granted Priority Review for the Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease, a rare type of autoimmune hemolytic anemia.
Vadadustat Noninferior to Darbepoetin Alfa for Anemia in Patients With Dialysis-Dependent CKD
The studies compared the efficacy and safety of vadadustat to darbepoetin alfa in adult patients on dialysis with anemia due to CKD.
FDA-Approved Biosimilars
A comparative list of biosimilars approved by the FDA including their reference products, dosage forms and indications.
Thromboembolic Disorder Treatments
Anticoagulants, antiplatelets, and thrombolytics for the treatment and/or prophylaxis of venous and arterial thrombosis.
Novel Pyruvate Kinase Activator Gets Orphan Drug Status for Sickle Cell Disease
The Food and Drug Administration (FDA) has granted Orphan Drug designation to FT-4202 (FORMA Therapeutics) for the treatment of sickle cell disease (SCD).
FDA Approves Reblozyl for Anemia in Patients With Myelodysplastic Syndromes
The FDA has approved Reblozyl® (luspatercept–aamt; Bristol-Myers Squibb and Acceleron) for the treatment of anemia in adults with lower-risk myelodysplastic syndromes.
Triferic AVNU Approved for Iron Replacement and Hemoglobin Maintenance in Dialysis Patients
The FDA has approved the New Drug Application for Triferic AVNU®.
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