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Recent Articles

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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

United Therapeutics files lawsuit against the FDA, alleging that the FDA erroneously allowed Liquidia to evade rules and procedures on pending drug approval applications; United Therapeutics claims this interfered with a pending patent infringement claim

United Therapeutics sues FDA for allegedly allowing rival Liquidia to amend a pending application for its competing drug treprostinil instead of starting a new submission; United claims the action skirts rules and infringes on patent law

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

FDA Approves Biweekly Dosing of Novel Bispecific Treatment for Relapsed/Refractory Multiple Myeloma, Expanding Patient Flexibility

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