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• US FDA expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit

  Media

  Jemperli approval now includes MMRp/MSS tumours, which represent majority of endometrial cancer cases.

  https://www.gsk.com/en-gb/media/press-releases/us-fda-expands-jemperli-dostarlimab-plus-chemotherapy-approval-to-all-adult-patients-with-primary-advanced-or-recurrent-endometrial-cancer/

  First published: 01 August 2024

• GSK and Zhifei revise and extend strategic vaccine collaboration in China

  Media

  Shingrix collaboration extended to 2034

  https://www.gsk.com/en-gb/media/press-releases/gsk-and-zhifei-revise-and-extend-strategic-vaccine-collaboration-in-china/

  First published: 05 December 2024

• US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD

  Media

  Nucala could be the first approved biologic with monthly dosing for patients with COPD

  https://www.gsk.com/en-gb/media/press-releases/us-fda-accepts-gsk-s-submission-for-the-use-of-nucala-mepolizumab-in-copd/

  First published: 09 December 2024

• Jemperli (dostarlimab) receives US FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer

  Media

  Designation based on data showing no evidence of disease in 100% of all 42 patients who completed treatment with dostarlimab.

  https://www.gsk.com/en-gb/media/press-releases/jemperli-dostarlimab-receives-us-fda-breakthrough-therapy-designation-for-locally-advanced-dmmrmsi-h-rectal-cancer/

  First published: 16 December 2024

• Jemperli (dostarlimab) plus Zejula (niraparib) combination significantly improved progression-free survival in primary advanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial

  Media

  Results reinforce development approach of using Jemperli as a backbone in immuno-oncology-based combination therapies

  https://www.gsk.com/en-gb/media/press-releases/jemperli-plus-zejula-combination-significantly-improved-progression-free-survival-in-endometrial-cancer-phase-iii-trial/

  First published: 18 December 2023

• GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for anaemia of CKD

  Media

  Daprodustat was studied in the ASCEND phase III clinical trial programme.

  https://www.gsk.com/en-gb/media/press-releases/gsk-reports-outcome-from-us-fda-advisory-committee-meeting-on-daprodustat-for-anaemia-of-ckd/

  First published: 27 October 2022

• GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress

  Media

  Improvements in lung function and health-related quality of life supported by statistically significant reductions in exacerbations

  https://www.gsk.com/en-gb/media/press-releases/gsk-presents-positive-results-from-phase-iii-fulfil-study-of-closed-triple-combination-therapy-ffumecvi-versus-symbicort-turbohaler-in-copd-at-ers-international-congress/

  First published: 06 September 2016

• GSK, Fondazione Telethon and Ospedale San Raffaele announce EU regulatory submission for gene therapy to treat rare disease ADA-SCID

  Media

  Today announced the submission of a marketing application to the EMA for a gene therapy (GSK2696273) to treat patients with a rare disease

  https://www.gsk.com/en-gb/media/press-releases/gsk-fondazione-telethon-and-ospedale-san-raffaele-announce-eu-regulatory-submission-for-gene-therapy-to-treat-rare-disease-ada-scid/

  First published: 05 May 2015

• GSK receives FDA approval for expanded indication for FluLaval® Quadrivalent (Influenza Vaccine) for infants 6 months and older

  Media

  An approval from the US Food and Drug Administration’s (FDA) Center

  https://www.gsk.com/en-gb/media/press-releases/gsk-receives-fda-approval-for-expanded-indication-for-flulaval-quadrivalent-influenza-vaccine-for-infants-6-months-and-older/

  First published: 18 November 2016

• GSK announces positive results from phase III trial of Nucala (mepolizumab) in COPD

  Media

  GSK announces positive headline results of MATINEE, the phase III clinical trial evaluating Nucala (mepolizumab) in adults with COPD.

  https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-phase-iii-trial-of-nucala-mepolizumab-in-copd/

  First published: 06 September 2024