Accelerated Approvals Withdrawn for Ibrutinib in Mantle Cell Lymphoma, Marginal Zone Lymphoma
April 7th 2023Accelerated approvals for ibrutinib (Imbruvica) for patients with mantle cell lymphoma and with marginal zone lymphoma voluntarily withdrawn based on data that were insufficient to support conversion to full approval.
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FDA Approves Evinacumab-dgnb for Young Children With Homozygous Familial Hypercholesterolemia
March 22nd 2023Evinacumab-dgnb (Evkeeza; Regeneron Pharmaceuticals, Inc) is the first FDA-approved treatment indicated for children as young as 5 years of age to treat dangerously high levels of LDL-C.
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FDA Approves Expanded Indication for Abemaciclib in HR+/HER2–, High-Risk Breast Cancer
March 6th 2023Indication for abemaciclib (Verzenio; Eli Lilly and Company) in combination with endocrine therapy expanded for the adjuvant treatment of adults with hormone receptor–positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer with a high risk of recurrence.
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Study Shows PCV13 Followed by PPSV23 Protects Against Pneumococcal Diseases in Patients With SCD
March 6th 2023The immunological efficacy of the 13-valent conjugate pneumococcal vaccine followed by 23-valent polysaccharide vaccine has been poorly documented in adult patients with sickle cell disease.
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FDA Approves First-in-Class Factor VIII Therapy for Hemophilia A
February 24th 2023Altuviiio [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl; Sanofi] is high-sustained factor VIII replacement therapy indicated for routine prophylaxis and on-demand treatment to control bleeding episodes and for perioperative management in adults and children with hemophilia A.
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FDA Approves Expanded Indication for Abrocitinib to Include Adolescents With Atopic Dermatitis
February 13th 2023Expanded indication for abrocitinib (Cibinqo; Pfizer Inc) includes patients 12 to <18 years of age with refractory, moderate-to-severe atopic dermatitis that is not adequately controlled with other systemic medications.
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