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 approval for Merck’s venerable Temodar (temozolomide).
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