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 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.
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New data at ASH underscore the potential for durable, clinically important responses with momelotinib for myelofibrosis patients
GSK today announced new 48-week data from the MOMENTUM phase III trial...
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Statement: Zantac (ranitidine) litigation
MDL Court has dismissed all cases alleging the five remaining cancers in the MDL
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Jemperli (dostarlimab-gxly) RUBY phase III trial met its primary endpoint in a planned interim analysis in patients with primary advanced or recurrent endometrial cancer
Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival
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New global survey reveals opportunities to address organ damage risk with people living with lupus earlier in the course of their disease
Survey examined healthcare professional approaches to preventing organ damage
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GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorization
GSK initiates the process for withdrawal of the US marketing authorization for Blenrep following the request of the FDA.
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US FDA approves new fully liquid presentation of GSK’s ROTARIX vaccine to prevent gastroenteritis caused by rotavirus
New fully liquid formulation of ROTARIX removes the need to reconstitute prior to administration, for improved convenience
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GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
The US FDA has accepted a Biologics License Application and granted Priority Review for its RSV older adult vaccine candidate.
