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New Shingrix data demonstrate 100% vaccine efficacy in the prevention of shingles in adults aged 50 and over in China
Media
No cases of shingles (herpes zoster) reported among the participants who received Shingrix in the randomised clinical trial
https://www.gsk.com/en-gb/media/press-releases/new-shingrix-data-demonstrate-100-vaccine-efficacy-in-prevention-shingles/
First published: 23 August 2023
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Phase III RUBY trial of Jemperli (dostarlimab) plus chemotherapy meets endpoint of overall survival in patients with primary advanced or recurrent endometrial cancer
Media
Statistically significant and clinically meaningful overall survival benefit observed in the overall population in the trial.
https://www.gsk.com/en-gb/media/press-releases/phase-iii-ruby-trial-of-jemperli-dostarlimab-plus-chemotherapy-meets-endpoint-of-overall-survival-in-patients-with-primary-advanced-or-recurrent-endometrial-cancer/
First published: 30 October 2023
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Japan’s Ministry of Health, Labour and Welfare accepts Arexvy (RSV vaccine) regulatory application to prevent RSV disease in adults aged 50-59 at increased risk
Media
Submission supported by positive results of a Phase III study showing immune response and safety in adults aged 50-59.
https://www.gsk.com/en-gb/media/press-releases/japan-accepts-arexvy-regulatory-application-to-prevent-rsv-disease-in-adults-aged-50-59/
First published: 12 December 2023
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GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the European Medicines Agency for the prevention of RSV disease in adults aged 50-59 at increased risk
Media
Application supported by positive results of a Phase III study showing immune response and acceptable tolerability profile.
https://www.gsk.com/en-gb/media/press-releases/arexvy-accepted-for-regulatory-review-by-ema-for-prevention-of-rsv-in-adults-50-59/
First published: 29 January 2024
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US FDA accepts for priority review GSK’s application for an expanded indication of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer
Media
Application supported by statistically significant and clinically meaningful progression-free and overall survival data from RUBY trial
https://www.gsk.com/en-gb/media/press-releases/fda-accepts-gsk-application-expanded-indication-of-jemperli-dostarlimab-plus-chemotherapy-include-all-adult-patients-primary-advanced-recurrent-endometrial-cancer/
First published: 24 April 2024
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Jemperli (dostarlimab) plus chemotherapy receives positive CHMP opinion to expand approval to all adult patients with primary advanced or recurrent endometrial cancer
Media
Positive opinion based on statistically significant and clinically meaningful progression-free and overall survival data.
https://www.gsk.com/en-gb/media/press-releases/jemperli-dostarlimab-plus-chemotherapy-receives-positive-chmp-opinion-to-expand-approval-to-all-adult-patients-with-primary-advanced-or-recurrent-endometrial-cancer/
First published: 16 December 2024
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GSK announces FIRST trial met its primary endpoint of progression free survival in first line advanced ovarian cancer
Media
GSK announces headline results from the FIRST-ENGOT-OV44 phase III trial.
https://www.gsk.com/en-gb/media/press-releases/gsk-announces-first-trial-met-its-primary-endpoint-of-progression-free-survival-in-first-line-advanced-ovarian-cancer/
First published: 20 December 2024
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Codes, standards and reports
Company
Find out about our codes, standards and reports
https://www.gsk.com/en-gb/company/codes-standards-and-reports/
First published: 20 March 2025
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Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older
Media
Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 years.
https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/
First published: 25 March 2025
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GSK and Theravance announce results from the SUMMIT COPD CV Survival Study
Media
GSK and THRX announced initial results from study for Relvar®Breo® Ellipta® 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’).
https://www.gsk.com/en-gb/media/press-releases/gsk-and-theravance-announce-results-from-the-summit-copd-cv-survival-study/
First published: 08 September 2015