Familiarity was the name of the game for the US FDA over the past two weeks, thanks to return engagements with Takeda Pharmaceutical Co. Ltd.’s TAK-721 and Orexo US Inc’s high-dose naloxone nasal spray and a second BLA for BeiGene’s tislelizumab.
FDA’s Project Renewal, which aims to bring older cancer drug labeling into current relevancy, issued its second label update with an
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