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• GSK and Save the Children call for developing country innovations to enter $1 million award

  Media

  GSK and Save the Children today launched their fourth annual $1 million Healthcare Innovation Award.

  https://www.gsk.com/en-gb/media/press-releases/gsk-and-save-the-children-call-for-developing-country-innovations-to-enter-1-million-award/

  First published: 07 July 2016

• GSK, Fondazione Telethon and Ospedale San Raffaele announce publication of pivotal safety and efficacy of gene therapy for children with ADA-SCID

  Media

  GSK today announced the publication in BLOOD of the long-term safety and efficacy data from an analysis of 18 children with ADA-SCID

  https://www.gsk.com/en-gb/media/press-releases/gsk-fondazione-telethon-and-ospedale-san-raffaele-announce-publication-of-pivotal-safety-and-efficacy-of-gene-therapy-for-children-with-ada-scid/

  First published: 25 May 2016

• European agency endorses antiseptic gel, developed through GSK and Save the Children partnership, for newborn umbilical cord infections in developing countries

  Media

  Milestone for GSK and Save the Children partnership and its mission to help save the lives of children in the world’s poorest communities

  https://www.gsk.com/en-gb/media/press-releases/european-agency-endorses-antiseptic-gel-developed-through-gsk-and-save-the-children-partnership-for-newborn-umbilical-cord-infections-in-developing-countries/

  First published: 29 April 2016

• ViiV Healthcare extends Medicines Patent Pool licence agreement for dolutegravir to cover all lower middle-income countries

  Media

  Follows announcement by majority shareholder GSK to expand graduated approach to patents and intellectual property (IP)

  https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-extends-medicines-patent-pool-licence-agreement-for-dolutegravir-to-cover-all-lower-middle-income-countries/

  First published: 25 April 2016

• GSK announces approval of Shingrix in China for prevention of shingles in adults aged 50 and over

  Media

  Shingrix is a recombinant subunit adjuvanted vaccine given intramuscularly in two doses.

  https://www.gsk.com/en-gb/media/press-releases/gsk-announces-approval-of-shingrix-in-china-for-prevention-of-shingles-in-adults-aged-50-and-over/

  First published: 23 May 2019

• 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