GSK Says FDA Accepts Momelotinib's New Drug Application
17 Agosto 2022 - 3:46AM
Dow Jones News
By Anthony O. Goriainoff
GSK PLC said Wednesday that momelotinib's new drug application,
or NDA, has been accepted by the U.S. Food and Drug Administration
for the treatment of myelofibrosis.
The U.K. pharmaceutical company said the FDA assigned a
Prescription Drug User Fee Act, or PDUFA, action date of June 16,
2023.
The PDUFA refers to the date by which the agency's review
process must be completed.
The FTSE 100-listed company said the NDA is based on results
from key Phase 3 trials which met all primary and key secondary
endpoints, and added that momelotinib wasn't currently approved in
any market.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
August 17, 2022 02:31 ET (06:31 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
Gsk (LSE:GSK)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
Gsk (LSE:GSK)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024
