GSK announces extension of FDA review period for momelotinib

GSK plc announced that the U.S. Food and Drug Administration has extended the review period of the new drug application, or NDA, for momelotinib by three months to provide time to review recently submitted data. The extended action date is September 16, 2023. “GSK is confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review. Momelotinib is not currently approved in any market,” the company stated.