FDA extends review of GSK’s myelofibrosis drug
Pharmaceutical Technology
JUNE 19, 2023
UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. The reason for this review extension was undisclosed in the announcement.
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