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• 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

• Jesduvroq (daprodustat) approved by US FDA for anaemia of chronic kidney disease in adults on dialysis

  Media

  Jesduvroq is the only oral HIF-PHI approved in the US, offering adults on dialysis with anaemia of CKD a new oral treatment option

  https://www.gsk.com/en-gb/media/press-releases/jesduvroq-daprodustat-approved-by-us-fda-for-anaemia-of-chronic-kidney-disease-in-adults-on-dialysis/

  First published: 01 February 2023

• US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli (dostarlimab-gxly) as a potential treatment for mismatch repair-deficient/microsatellite instability-high locally advanced rectal cancer

  Media

  In January 2023, the US FDA granted dostarlimab-gxly Fast Track designation for the treatment of dMMR/MSI-H locally advanced rectal cancer.

  https://www.gsk.com/en-gb/media/press-releases/us-fda-advisory-committee-votes-in-support-of-trials-designed-to-evaluate-jemperli-dostarlimab-gxly-as-a-potential-treatment-for-dmmrmsi-h-locally-advanced-rectal-cancer/

  First published: 09 February 2023

• US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer

  Media

  Conversion from accelerated to regular (full) approval based on long-term outcomes from the GARNET phase I trial

  https://www.gsk.com/en-gb/media/press-releases/us-fda-grants-regular-approval-for-jemperli-for-the-treatment-of-patients-with-recurrent-or-advanced-mismatch-repair-deficient-endometrial-cancer/

  First published: 10 February 2023

• GSK reaches agreement to acquire late-stage biopharmaceutical company BELLUS Health

  Media

  Acquisition further strengthens specialty medicines and respiratory pipeline.

  https://www.gsk.com/en-gb/media/press-releases/gsk-reaches-agreement-to-acquire-late-stage-biopharmaceutical-company-bellus-health/

  First published: 18 April 2023

• GSK receives US FDA file acceptance for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer

  Media

  Submission accepted for Priority Review

  https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-file-acceptance-for-jemperli/

  First published: 06 June 2023

• Jemperli (dostarlimab) plus chemotherapy approved in the US as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer

  Media

  Jemperli is the only immuno-oncology treatment approved in a frontline setting for this patient population in combination with chemotherapy

  https://www.gsk.com/en-gb/media/press-releases/jemperli-plus-chemotherapy-approved-in-us-for-new-indication/

  First published: 31 July 2023

• GSK and Zhifei announce exclusive strategic vaccine partnership in China

  Media

  Partnership will significantly extend availability of Shingrix in China with co-promotion to healthcare professionals.

  https://www.gsk.com/en-gb/media/press-releases/gsk-and-zhifei-announce-exclusive-strategic-vaccine-partnership-in-china/

  First published: 09 October 2023

• GSK receives positive CHMP opinion recommending approval of Jemperli (dostarlimab) plus chemotherapy as a new frontline treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer

  Media

  Decision on EU marketing authorisation expected by the end of the year.

  https://www.gsk.com/en-gb/media/press-releases/gsk-receives-positive-chmp-opinion-recommending-approval-of-jemperli-dostarlimab-plus-chemotherapy/

  First published: 16 October 2023

• GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia

  Media

  Decision on EU marketing authorisation expected for momelotinib by early 2024.

  https://www.gsk.com/en-gb/media/press-releases/gsk-receives-positive-chmp-opinion-recommending-momelotinib-for-myelofibrosis-patients-with-anaemia/

  First published: 13 November 2023