Today, GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has extended the review period of the New Drug Application (NDA) for momelotinib by an additional three months to allow for the evaluation of newly submitted data.
The revised completion date is now set for 16th September 2023. Despite this extension, GSK maintains its confidence in the momelotinib NDA and anticipates a productive collaboration with the FDA during the final stages of their review. As of now, momelotinib is yet to receive approval in any market.
More details can be found here.