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Keeping Track: US FDA Is Approving JAK Inhibitors Again, Starting With Incyte’s Opzelura; Seagen’s Tivdak Cleared

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Keeping Track Feature image

The autumn season started with a thaw in the US FDA’s stance on the Janus kinase (JAK) inhibitor class, where activity on pending applications had frozen while the agency was it moved to strengthen warnings on some drugs in the class. Incyte emerged the winner with FDA clearance of the first topical formulation of a JAK inhibitor, Opzelura for atopic dermatitis, and approval of a new indication for oral Jakafi.

Seagen Inc

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