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Home » Recorlev wins FDA nod for Cushing’s syndrome patients
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Recorlev wins FDA nod for Cushing’s syndrome patients

Dec. 31, 2021
By Jennifer Boggs and Michael Fitzhugh
Less than three months after completing its acquisition of Strongbridge Biopharma plc, Xeris Biopharma Holdings Inc. secured FDA approval of Recorlev (levoketonconazole), a second-generation drug cleared for use in Cushing’s syndrome, just ahead of its Jan. 1 PDUFA date. Indicated specifically for patients with endogenous forms of the disease for whom surgery isn’t an option or hasn’t worked, the therapy is expected to be available commercially in the first quarter of 2022.
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