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Recent Articles

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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

FDA approves J&J's supplemental application for a reduced dosing regimen of TECVAYLI, an injectable medicine for patients with relapsed or refractory multiple myeloma; the approval will enable biweekly, weight-based dosing, adding flexibility for patients

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