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Latest From Exelixis, Inc.
FDA also approves packaging redesign for Mucinex and Mucinex-DM and final changes to labeling text and location on packaging. Granules Pharmaceuticals’ generic of Excedrin Migraine also among CDER’s decisions on OTC ANDAs and sNDAs during January-March.
Plus deals involving I-Mab/Complix, Lupin/Endoceutics, Genome & Co/Pfizer/Merck KGaA, Genome & Co/Debiopharm, Exelixis/WuXi, Intas/Foresee, Wugen/Alpha Biosciences
The approval marks the first commercial launch for Aveo in the US, but tivozanib has shown modest efficacy in cancer and the approval is relegated to later lines.
Settlement in Southern District of Florida federal court includes a consolidated class action complaint against UK firm’s US businesses comprising cases in Florida, New York and California – filed in 2020 over statements the products were “clinically proven” to improve “brain performance” including focus, memory, learning, accuracy, concentration and reasoning.
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- X-Ceptor Therapeutics, Inc.