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.
GSK plc reports developments across its global biopharma business, including vaccines, respiratory medicines, infectious disease, immunology and oncology programs. Recurring updates include regulatory decisions and clinical evidence for products such as AREXVY, GSK's RSV vaccine, and Exdensur for severe asthma, along with data presentations, product indications and therapeutic-area access initiatives.
GSK news also covers manufacturing and supply agreements, commercial collaborations, public-health grant programs and product partnerships tied to its medicine and vaccine portfolio. As an American Depositary Share issuer, company updates may reflect both parent-company announcements and ADR-related market disclosures.
GSK (NYSE: GSK) on May 7, 2026 launched the Ask2BSure campaign with spokespeople Julie Bowen and Ty Burrell to raise awareness of meningococcal disease risk among teens and young adults ages 16–23. The campaign video, The Mening-Itinerary, is available on GSK’s YouTube channel and Ask2BSure.com. The release notes meningitis can kill in 10–15% of cases and that 1 in 5 survivors may face long-term effects such as amputation, brain damage, or hearing loss, urging parents to ask clinicians about missing meningitis B vaccination.
GSK (NYSE: GSK) announced that the FDA expanded AREXVY's approved US indication to include adults aged 18–49 years at increased risk for RSV-related lower respiratory tract disease (LRTD). The decision (March 13, 2026) cites Phase IIIb non-inferior immune responses and prior efficacy and safety data.
The release notes annual US burden estimates for 18–49-year-olds: ~17,000 hospitalizations, 277,000 ED admissions and 1.97 million outpatient visits, and reiterates common, mostly short-lived adverse events.
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.