GSK Gets Extension to FDA Review Period for Momelotinib Treatment
June 16 2023 - 2:46AM
Dow Jones News
By Joe Hoppe
GSK PLC said Friday that the U.S. Food and Drug Administration
has extended the review period of its new drug application for its
momelotinib treatment for myelofibrosis by three months, to review
recently submitted data.
The pharma major said the extended action date is now Sept.
16.
The company said it was confident in its application and looks
forward to working with the FDA as it finalises its review.
Momelotinib isn't currently approved in any market.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
June 16, 2023 02:31 ET (06:31 GMT)
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