Welcome to our dedicated page for GSK PLC news (Ticker: GSK), a resource for investors and traders seeking the latest updates and insights on GSK PLC stock.
News and regulatory disclosures for GSK plc (GSK) highlight the company’s ongoing activity across medicines, vaccines and strategic collaborations. As a global biopharma company, GSK regularly reports clinical trial milestones, product approvals, public health initiatives and agreements with partners and governments.
Recent news includes multiple regulatory approvals and data readouts in respiratory medicine. GSK has announced approvals for Exdensur (depemokimab) in markets such as Japan for severe asthma and chronic rhinosinusitis with nasal polyps, based on the SWIFT and ANCHOR phase III trials. The company has also reported that Nucala (mepolizumab) was approved in China as an add-on maintenance treatment for adults with COPD characterized by raised blood eosinophils, supported by the MATINEE and METREX studies.
In vaccines, GSK issues updates on Shingrix, including US FDA and European Commission approvals of a prefilled syringe presentation designed to simplify administration, and on its seasonal influenza vaccines FLULAVAL and FLUARIX, which are shipped ahead of each US flu season following FDA lot-release. News about Vaccine Track, GSK’s public data tool for US adult immunization trends, provides additional context on the company’s role in vaccination and public health analytics.
Oncology and specialty medicine updates feature prominently in GSK news. The company has reported US FDA approval of Blenrep in combination regimens for relapsed or refractory multiple myeloma, as well as positive phase III results for bepirovirsen in chronic hepatitis B with plans for global regulatory submissions. Additional releases describe collaborations with partners such as Hengrui Pharma and Summit Therapeutics to develop new respiratory, immunology & inflammation and oncology programs.
Investors and observers following GSK news can expect coverage of clinical trial outcomes, regulatory decisions, pricing and access agreements, and community initiatives such as the Linked by Lupus: Optimal Care Initiative. Bookmarking this page provides a centralized view of GSK’s latest announcements and SEC-reported developments.
Bora Pharmaceuticals and GSK (LSE/NYSE: GSK) renewed a five-year global manufacturing agreement through 2030, a deal reported at $250 million. The renewal gives GSK access to multiple Bora sites, including a new oral solid dose facility in Maple Grove, Minnesota.
Bora will continue manufacturing more than 20 commercial product lines (over 335 individual products) at its Mississauga site, supporting infectious disease, mental health, dermatology and other therapeutic areas.
GSK (GSK) presented real-world effectiveness data for AREXVY at RSVVW’26 showing associations with reduced RSV-related risks in adults ≥60 years. In a US cohort (520,440 vaccinated; 2,081,760 matched unvaccinated) AREXVY was associated with 75.6% VE against RSV-related hospitalization (median follow-up 5.6 months). Exploratory analyses associated AREXVY with 63.1% VE against MACE and 74.4% / 61.6% VE against severe COPD and asthma flare-ups, respectively. A Danish COPD cohort reported 100% VE for RSV-related hospitalization (95% CI 71.1–100%). Observational design prevents causal claims.
GSK (NYSE: GSK) awarded $2 million in 2025 COiMMUNITY Initiative grants to 16 US non‑profits focused on improving vaccine education, outreach and immunization systems.
The program targets modernized outreach, provider training and community advocacy; 2025 grantees include national groups such as the American College of Physicians, American Heart Association and National Council on Aging, plus local coalitions.
GSK committed $3 million for 2026 grants; applications are open at gskgrants.com and will be reviewed on a rolling basis through mid‑November 2026.
GSK (NYSE: GSK) awarded nearly $1 million in Linked by Lupus: Optimal Care Initiative grants to support community programs across the United States focused on systemic lupus erythematosus (SLE) and lupus nephritis (LN).
Launched in June 2025, the initiative funds community-driven projects that aim to improve earlier diagnosis, increase awareness and access to evidence-based treatments, and enhance patient–provider communication. 13 grantees were selected, including national and local non-profits such as the Autoimmune Association, Lupus LA, National Kidney Foundation, and multiple Lupus Foundation of America chapters. GSK emphasized this as part of its ongoing commitment to expand resources and support for people living with lupus.
Summary not available.
Samsung Biologics announced that its U.S. subsidiary will acquire 100% of Human Genome Sciences from GSK (GSK), securing Samsung Biologics' first U.S. manufacturing site in Rockville, Maryland.
The Rockville facility comprises two cGMP plants with a combined 60,000 liters drug substance capacity; closing is anticipated toward the end of Q1 2026 for USD 280 million. Samsung Biologics will retain > 500 employees and plans further investments to expand capacity and upgrade technology to support clinical and commercial biologic production and U.S. supply‑chain resilience.
GSK (NYSE: GSK) announced US FDA approval of Exdensur (depemokimab) on December 17, 2025, as an add‑on maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged 12 and older.
Approval is based on SWIFT‑1 and SWIFT‑2 phase III data showing sustained benefit with twice‑yearly dosing: a 58% reduction (SWIFT‑1) and 48% reduction (SWIFT‑2) in annualized exacerbation rates versus placebo, and a pooled 72% reduction in exacerbations requiring hospitalization or ED visits over 52 weeks.
GSK (NYSE: GSK) announced FDA approval of Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma after ≥2 prior lines, including a PI and an IMID, on October 24, 2025.
Approval is supported by DREAMM-7 phase III results showing a 51% reduction in risk of death (HR 0.49) and a tripling of median PFS to 31.3 months vs 10.4 months (DVd) in 3L+ patients. A streamlined REMS and a US patient support program are available. Global regulatory reviews and ongoing DREAMM studies with OS follow-up and earlier-line trials continue, with key data expected in early 2028.
GSK (NYSE:GSK) has announced a significant expansion of its Vaccine Track tool, the only public platform tracking monthly adult immunization trends in the US. The enhanced platform now covers 387 metro areas and includes a decade of historical data, providing deeper local-level insights into vaccination patterns.
The update reveals that while most metro areas saw vaccination increases in Q1 2025 compared to Q1 2024, about 20% experienced declines. This variation highlights opportunities for targeted public health interventions. The tool aims to address the significant economic burden of vaccine-preventable diseases, which cost the US up to $9 billion annually in medical costs and productivity losses, with 80% linked to unvaccinated adults.
GSK (NYSE:GSK) has entered into strategic agreements with Hengrui Pharma to develop up to 12 innovative medicines in Respiratory, Immunology & Inflammation, and Oncology. GSK will pay $500 million in upfront fees and potential milestone payments of up to $12 billion.
The deal includes an exclusive worldwide license (excluding Greater China region) for HRS-9821, a potential best-in-class PDE3/4 inhibitor for COPD treatment. Additionally, Hengrui will develop 11 other programs through Phase I, with GSK holding exclusive options for worldwide commercialization rights.
HRS-9821 has shown promising results in early clinical studies, demonstrating potent bronchodilation and anti-inflammatory effects, with the potential for convenient dry-powder inhaler formulation.