Thromboembolic Disorder Treatments
Anticoagulants, antiplatelets, and thrombolytics for the treatment and/or prophylaxis of venous and arterial thrombosis.
Hematologic Disorders
Ultomiris Receives Approval for Atypical Hemolytic Uremic Syndrome
The FDA has approved Ultomiris (ravulizumab-cwvz; Alexion) for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric patients aged 1 month and older.
FDA Approves Earlier Use of Nplate in Immune Thrombocytopenia
The FDA has approved the supplemental Biologics License Application for Nplate (romiplostim; Amgen) to expand treatment to newly diagnosed adult patients with immune thrombocytopenia.
FDA Approves Wilate for Hemophilia A in Adult and Adolescent Patients
The Food and Drug Administration (FDA) has approved Wilate (von Willebrand Factor/Coagulation Factor VIII Complex [Human]; Octapharma) for routine prophylaxis to reduce the frequency of bleeding episodes and on-demand treatment and control of bleeding episodes in patients with hemophilia A. The approval was based on data from the prospective, open-label, multicenter phase 3 trial that…
FDA-Approved Biosimilars
A comparative list of biosimilars approved by the FDA including their reference products, dosage forms and indications.
Investigational Therapy for Hemophilia A Granted Orphan Drug Designation
The Food and Drug Administration (FDA) has granted Orphan Drug designation to SIG-001 (Sigilon Therapeutics) for the treatment of hemophilia A. SIG-001 utilizes Sigilon’s Shielded Living Therapeutics platform to implant engineered human cells to produce stable blood plasma levels of factor VIII. The cells are also shielded by Sigilon’s proprietary Afibromer biomaterials matrix that minimizes…
Iron Deficiency Anemia Treatments
Recommendations for the management of iron deficiency anemia including oral and intravenous iron therapies.
Study Investigating Rivipansel in Patients With Sickle Cell Disease Misses End Points
The primary end point was time to readiness for discharge, defined as the difference between the readiness-for-discharge date and time and the start date and time of the first infusion of study drug.
Nipocalimab Gets Fast-Tracked for Hemolytic Disease of the Fetus and Newborn
The Food and Drug Administration (FDA) has granted Fast Track designation to nipocalimab (M281) for the prevention of hemolytic disease of the fetus and newborn (HDFN).
New Oral Therapy Approved for Iron Deficiency in Adults
The FDA has approved Accrufer (ferric maltol; Shield Therapeutics) for the treatment of iron deficiency in adults.
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