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• GSK expands graduated approach to patents and intellectual property to widen access to medicines in the world’s poorest countries

  Media

  GSK has a deep commitment to improving healthcare by developing innovative new medicines and widening access to them around the world.

  https://www.gsk.com/en-gb/media/press-releases/gsk-expands-graduated-approach-to-patents-and-intellectual-property-to-widen-access-to-medicines-in-the-world-s-poorest-countries/

  First published: 31 March 2016

• ViiV Healthcare announces Juluca (dolutegravir/rilpivirine) maintains HIV viral suppression at 148-weeks

  Media

  SWORD studies demonstrate long-term durable efficacy and tolerability of Juluca for treatment of virologically suppressed adults with HIV

  https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-juluca-dolutegravirrilpivirine-maintains-hiv-viral-suppression-at-148-weeks/

  First published: 03 April 2019

• Shingrix approved in the US for prevention of shingles in immunocompromised adults

  Media

  Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals

  https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-immunocompromised-adults/

  First published: 26 July 2021

• 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