Press releases
Browse GSK global press releases issued since 2009. Search them by keyword or browse by year/business category.
Press releases issued by our local operating companies can be viewed on our market websites.
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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
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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
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GSK momentum continues with strong start to 2023
Q1 2023 performance highlights
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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
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GSK reaches agreement to acquire late-stage biopharmaceutical company BELLUS Health
Acquisition further strengthens specialty medicines and respiratory pipeline.
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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
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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.
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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.
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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.
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Statement: Zantac (ranitidine) litigation
In response to the Sargon ruling by the California state court in respect of the Goetz case, GSK plc issued the following statement.
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China National Medical Products Administration accepts regulatory submission for Nucala (mepolizumab) in severe eosinophilic asthma
The China National Medical Products Administration (NMPA) has accepted for review a new drug application for Nucala (mepolizumab)
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GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate
MenABCWY combination vaccine candidate met all its primary endpoints of the pivotal phase III clinical trial
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US FDA Advisory Committee votes to support effectiveness and safety of GSK’s respiratory syncytial virus older adult vaccine candidate
Committee votes unanimously that the data support the effectiveness of the vaccine and 10-2 that the data support the safety of the vaccine
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ViiV Healthcare announces positive data demonstrating long-acting injectable Cabenuva (cabotegravir, rilpivirine) is as effective as daily oral Biktarvy (BIC/FTC/TAF) for the treatment of HIV-1
ViiV Healthcare announced positive 12-month findings from the SOLAR study.
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Landmark New England Journal of Medicine publication reinforces potential of GSK’s respiratory syncytial virus older adult vaccine candidate
First peer-reviewed publication of phase III RSV vaccine data in older adults, including those with comorbidities who are most at risk.
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ViiV Healthcare to present first head-to-head data for long-acting HIV treatment Cabenuva against daily oral Biktarvy at CROI 2023
Other key data to be presented include new HIV prevention findings for long-acting cabotegravir and predictors of response to N6LS
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US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer
Conversion from accelerated to regular (full) approval based on long-term outcomes from the GARNET phase I trial
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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
In January 2023, the US FDA granted dostarlimab-gxly Fast Track designation for the treatment of dMMR/MSI-H locally advanced rectal cancer.
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GSK announces results from 17-year retrospective study on US clinical trial diversity
Study examined clinical trial diversity across 495 GSK trials involving over 100,000 participants.
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Jesduvroq (daprodustat) approved by US FDA for anaemia of chronic kidney disease in adults on dialysis
Jesduvroq is the only oral HIF-PHI approved in the US, offering adults on dialysis with anaemia of CKD a new oral treatment option
