News
GSK announces extension of FDA review period for momelotinib to treat myelofibrosis.
GSK plc announced that the FDA has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data.
The extended action date is 16 September 2023. GSK is confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review.
Momelotinib, if approved, would be the only medicine that addresses key manifestations of myelofibrosis, including anaemia, symptoms, and splenomegaly.
Condition: Myelofibrosis
Type: drug
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