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Eli Lilly: FDA Issues CRL For Lebrikizumab BLA Related To Third-party Manufacturing Organization

Por: RTTNews Health October 02, 2023

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Eli Lilly and Company () announced the FDA has issued a complete response letter for the lebrikizumab biologic license application for the treatment of moderate-to-severe atopic dermatitis. The company said the FDA letter cited findings that arose during a multi-sponsor inspection of a third-party, contract manufacturing organization that included the monoclonal antibody drug substance for Lilly's lebrikizumab.We are confident in... + full article



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