Keeping Track: Takeda’s Exkivity Clears US FDA; BeiGene’s Busy Summer
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Access to Takeda’s lung cancer drug, Exkivity, is being fast-tracked, and BioMarin’s Vimizin, for mucopolysaccharidosis type 4A, is switching to routine use after what the MPS Society called “a long and at times difficult journey.”
Along with Skyrizi’s expected approval in Crohn’s, AbbVie says Rinvoq in ulcerative colitis is key to its Humira sales erosion strategy. It is Rinvoq’s third US supplemental approval since December.
CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.