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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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.
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GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for anaemia of CKD
Daprodustat was studied in the ASCEND phase III clinical trial programme.
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GSK announces expanded collaboration with Tempus in precision medicine to accelerate R&D
GSK will work together with Tempus to improve clinical trial design, speed up enrolment and identify drug targets.
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US FDA approves Menveo in a new single-vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W
The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option.
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GSK to present updates on its industry-leading infectious disease portfolio at IDWeek 2022
GSK will share updates on its industry-leading infectious disease pipeline and portfolio with 33 abstracts accepted for IDWeek 2022.
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US FDA approves Boostrix for immunization during pregnancy for the prevention of whooping cough in newborn infants
The FDA has approved Boostrix for immunization during the third trimester of pregnancy to help prevent pertussis (whooping cough).
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Oncologic Drugs Advisory Committee to review Zejula overall survival data from the NOVA phase III trial in recurrent ovarian cancer
The US FDA will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss overall survival data from the Nova trial
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GSK and Spero Therapeutics announce exclusive licence agreement for tebipenem HBr, a late-stage antibiotic that may treat complicated urinary tract infections
GSK and Spero Therapeutics announce exclusive licence agreement for tebipenem HBr
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GSK announces update on US FDA regulatory review of daprodustat in anaemia of chronic kidney disease
GSK today announced that the US FDA will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review daprodustat