Press releases
Browse US-specific press releases here.
Please visit our Global website for access to global press releases dating back to 2009.
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GSK announces AREXVY, its respiratory syncytial virus (RSV) vaccine, is now available at all major US retail pharmacies
AREXVY is now widely available in major retail pharmacies and anticipated to be covered by most Medicare and commercial insurance plans.
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Jemperli (dostarlimab-gxly) 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
Jemperli is the only immuno-oncology treatment approved in a frontline setting for this patient population in combination with chemotherapy
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GSK is first to ship influenza vaccine doses for the 2023-24 flu season in US
GSK supports annual flu immunization with its shipping of FLULAVAL QUADRIVALENT and FLUARIX QUADRIVALENT
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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
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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
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GSK shares positive data for AREXVY, its respiratory syncytial virus (RSV) older adult vaccine, indicating protection over two RSV seasons
GSK shares positive data for AREXVY, its respiratory syncytial virus older adult vaccine, indicating protection over two RSV seasons
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GSK and Lifetime® Release Short Film Featuring Soleil Moon Frye and Melissa Joan Hart Urging Parents to “Ask2BSure” about Meningitis B
The film, “I Never Thought to Ask: A Mom's Quest for Answers” includes important questions parents can ask their teen’s doctor.
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GSK receives US FDA file acceptance for Jemperli (dostarlimab-gxly) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer
Submission accepted for Priority Review.
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GSK announces the COiMMUNITY Initiative to help achieve higher adult vaccination rates in the US
The COiMMUNITY Initiative is designed to help reduce health inequities and set a new precedent for adult immunization rates in the US.
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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 reaches agreement to acquire late-stage biopharmaceutical company BELLUS Health
Acquisition further strengthens specialty medicines and respiratory pipeline.
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Phase III RUBY clinical trial demonstrates potential of Jemperli (dostarlimab-gxly) 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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GSK and Earvin “Magic” Johnson Partner to Raise Awareness of Risk of RSV in Older Adults
GSK launches national health education campaign, Sideline RSV, to highlight risk of Respiratory Syncytial Virus (RSV).
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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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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
This approval is based on additional data collected from the A1 expansion cohort of the ongoing GARNET trial
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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 anemia 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
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Benlysta granted Orphan Drug Designation by US FDA for the potential treatment of systemic sclerosis
GSK plans to initiate a phase II/III trial for systemic sclerosis associated interstitial lung disease (SSc-ILD) in the first half of 2023.