Here's your US review and approval news this week in brief: FDA activity was quiet aside from the approval of Shionogi & Co. Ltd. and Roche’s Xofluza, with labeling updates for Takeda Pharmaceutical Co. Ltd. and Lundbeck Inc.’s Trintellix antidepressant, Novo Nordisk AS’s antidiabetic Saxenda, and Roche’s venerable Rituxan.
Xofluza brought the Center for Drug Evaluation and Research’s 2018 approvals to a record-breaking 47 new molecular entities and novel...
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