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

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

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Incyte, Syndax Team Up On Chronic GVHD, But Some Uncertainties Remain

The deal could nevertheless give Incyte a competitive edge, especially with combination potential between its JAK inhibitors and Syndax’s axatilimab.

Incyte Plays Down Ruxolitinib Cream Label Worries Following Atopic Dermatitis Approval

Incyte welcomed FDA approval of its ruxolitinib cream, a selective JAK1/JAK2 inhibitor, as a treatment for atopic dermatitis, but criticized the boxed warnings label assigned to it.

Seagen/Genmab's Tivdak Set To Take On Merck’s Keytruda

Accelerated approval of Tivdak in recurrent or metastatic cervical cancer brings Seagen’s fourth cancer therapy and third antibody-drug conjugate to market. Merck is advancing Keytruda in r/mCC as well.

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