Drug Approval | November 21, 2023
GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
Decision on EU marketing authorisation expected for momelotinib by early 2024
Decision on EU marketing authorisation expected for momelotinib by early 2024
General Medicine grows 5% and Vaccines 10% led by Shingrix
Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing
Pfizer is likely to show GSK significant competition
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
SCYNEXIS will receive an upfront payment of $90 million with future performance-based milestone payments and tiered royalties
Company to open new headquarters in 2024
48-week data from MOMENTUM phase III clinical trial show momelotinib maintained total symptom response
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