A comprehensive view of FDA Drug / Device Reviews. This page highlights a small sample of our full coverage.
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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
Published:
March 26, 2024
by Janssen Pharmaceutical Companies
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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
Published:
March 08, 2024
by Eli Lilly & Co.
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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
Published:
February 27, 2024
by AbbVie Inc.
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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
Published:
February 23, 2024
by Sanofi SA
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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
Published:
February 21, 2024
by Regeneron Pharmaceuticals Inc.
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