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• US Food and Drug Administration accepts New Drug Application for daprodustat

  Media

  US FDA regulatory submission acceptance is the third major regulatory milestone for daprodustat

  https://www.gsk.com/en-gb/media/press-releases/us-food-and-drug-administration-accepts-new-drug-application-for-daprodustat/

  First published: 19 April 2022

• GSK announces update on US FDA regulatory review of daprodustat in anaemia of chronic kidney disease

  Media

  GSK today announced that the US FDA will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review daprodustat

  https://www.gsk.com/en-gb/media/press-releases/gsk-announces-update-on-us-fda-regulatory-review-of-daprodustat-in-anaemia-of-chronic-kidney-disease/

  First published: 06 September 2022

• European Medicines Agency validates marketing authorisation application for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer

  Media

  Regulatory submission based on pivotal data from Part 1 of the RUBY phase III trial

  https://www.gsk.com/en-gb/media/press-releases/european-medicines-agency-validates-marketing-authorisation-application-for-jemperli-dostarlimab/

  First published: 25 April 2023

• GSK receives positive CHMP opinion recommending authorisation of daprodustat for symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis

  Media

  The positive CHMP opinion is based on data from three global phase III trials in dialysis patients from the ASCEND clinical trial programme.

  https://www.gsk.com/en-gb/media/press-releases/gsk-receives-positive-chmp-opinion/

  First published: 26 June 2023

• 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

• 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

• 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

• 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

• 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

• 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