Press release archive
Browse GSK's global press release archive for media and investors. Search by keyword or browse by year/business category.
Press releases issued by our local operating companies can be viewed on our market websites.
GSK receives US FDA Fast Track designation for investigational vaccine against gonorrhoea
Fast Track designation accelerates the vaccine candidate’s path to US FDA submission for the prevention of Neisseria gonorrhoeae infection
Japan’s Ministry of Health, Labour and Welfare approves Shingrix for the prevention of shingles in at-risk adults aged 18 and over
Approval expands the number of people who can be protected against shingles.
GSK receives positive CHMP opinion recommending authorisation of daprodustat for symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis
The positive CHMP opinion is based on data from three global phase III trials in dialysis patients from the ASCEND clinical trial programme.
Statement - Zantac (ranitidine) litigation
GSK today confirmed it has reached a confidential settlement with James Goetz.
US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices votes to recommend Arexvy for the prevention of RSV disease in adults aged 60 and older with shared clinical decision making
Committee recommendations mean over 55 million older adults in the US could have access to RSV vaccination for the first time
GSK shares positive data for Arexvy, its respiratory syncytial virus (RSV) older adult vaccine, indicating protection over two RSV seasons
Results from the ongoing AReSVi-006 phase III trial show vaccine efficacy over two full seasons
GSK announces extension of FDA review period for momelotinib
GSK is confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review.
European Commission authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults
Authorisation will help protect adults 60 years of age and older in 30 European countries from RSV disease for the first time
GSK receives US FDA file acceptance for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer
Submission accepted for Priority Review
GSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated coverage against a panel of 110 MenB strains
GSK today presented preliminary positive results from the phase III trial
Statement: Zantac (ranitidine) litigation
GSK welcomes the decision of the British Columbia Supreme Court in Dussiaume v. Sandoz Canada Inc. 2023 BCSC 795
US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
GSK’s respiratory syncytial virus older adult vaccine candidate gains positive European Medicines Agency CHMP opinion
Positive opinion advances GSK’s goal to provide the first vaccine to help protect older adults from respiratory syncytial virus disease
GSK momentum continues with strong start to 2023
Q1 2023 performance highlights
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
Regulatory submission based on pivotal data from Part 1 of the RUBY phase III trial
GSK reaches agreement to acquire late-stage biopharmaceutical company BELLUS Health
Acquisition further strengthens specialty medicines and respiratory pipeline.
Gepotidacin’s positive phase III data shows potential to be the first in a new class of oral antibiotics for uncomplicated urinary tract infections in over 20 years
Gepotidacin is a late-stage antibiotic in development in GSK’s growing infectious diseases portfolio
GSK and SCYNEXIS announce an exclusive agreement to commercialise and further develop Brexafemme (ibrexafungerp), a novel, first-in-class medicine to treat fungal infection
Brexafemme complements GSK’s industry-leading infectious disease portfolio with an FDA approved treatment for vulvovaginal candidiasis.
Medicines Patent Pool signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of ViiV Healthcare’s innovative long-acting HIV prevention medicine
Licences should enable potentially millions of people living in areas most impacted by HIV to access innovative prevention medicine.
Phase III RUBY clinical trial demonstrates potential of Jemperli (dostarlimab) plus chemotherapy to redefine the treatment of primary advanced or recurrent endometrial cancer versus chemotherapy alone
Interim results from Part 1 of the RUBY clinical trial in primary advanced or recurrent endometrial cancer.