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Recent Articles

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FDA grants Fast Track designation to J&J's nipocalimab injectable for FNAIT treatment, a potentially life-threatening condition affecting pregnant women's immune response to fetal platelets; it is the only therapy in clinical development for the disorder

FDA to hold advisory committee meeting to discuss Phase 3 trial of Eli Lilly's Alzheimer drug, donanemab, delaying expected action on the drug beyond Q1 2024; the action does not change Lilly 's 2024 financial guidance

FDA grants priority review to AbbVie's SBLA for epcoritamab-bysp, a subcutaneously administered T-cell engaging bispecific antibody for the treatment of adult relapsed or refractory follicular lymphoma; AbbVie and Genmab are co-developing epcoritamab

FDA accepts Sanofi's supplementary application for priority review of Dupixent as a potential treatment for moderate to severe chronic obstructive pulmonary disease with type 2 inflammation; a decision is expected by June 27, 2024

FDA grants priority review to Regeneron's BLA for linvoseltamab as a treatment for multiple myeloma, decision date is set for August 22, 2024; European medicines agency accepted the drug for review earlier this month

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