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 (GSK) has received FDA approval for Hibsago (bepirovirsen) in combination with antiviral therapy for eligible adults with chronic hepatitis B. Eligibility requires no cirrhosis, at least six months of nucleos(t)ide analogue reverse transcriptase inhibitor therapy, suppressed viral DNA and hepatitis B surface antigen (HBsAg) ≤3000 IU/ml on an FDA-authorised test.
In pooled B-Well phase III trials, six-month treatment achieved 19% functional cure (233 of 1,220), versus 0 of 614 receiving placebo. Both trials met their primary endpoint. The ≤1000 IU/ml HBsAg subgroup achieved 26% functional cure, versus none with placebo. Hibsago carries a boxed warning for on-treatment hepatic flares and thrombocytopenia, a potentially life-threatening reduction in platelets. GSK anticipates regulatory decisions in additional geographies in the coming months.
GSK (GSK) received US accelerated approval for Jemperli monotherapy in adults with stage II/III MSI-H/dMMR locally advanced rectal cancer. Eligibility requires an FDA-authorized test identifying these tumor biomarkers, which reflect impaired DNA repair.
In phase II AZUR-1, investigator assessment found 68% (98/144) of evaluable patients maintained a clinical complete response—no detectable cancer—for 12 months without surgery. Independent Central Review found 47% (54/116); those data continue to mature. An exploratory analysis including surgery-confirmed responses found 76% (110/144) had no evidence of cancer one year or more after treatment. No recurrences were reported among responders after median follow-up exceeding two years.
Serious adverse reactions occurred in 20%. Long-term relapse risk is unknown; continued approval may depend on confirmatory trials verifying clinical benefit.
GSK (GSK) partnered with Viola Davis to launch a national shingles education campaign for adults aged 50 and older. The “Shingles, actually” campaign features Davis discussing her own experience with shingles, including its impact on her work and personal life.
The campaign encourages adults to discuss shingles risk and prevention with their doctor or pharmacist. GSK said insights into adults’ views on health, aging and shingles shaped the campaign. Educational content is available at ShinglesActually.com and through the campaign’s Instagram channel.
GSK (NYSE:GSK) announced that the US FDA has approved Jideytro (zidesamtinib), a ROS1-selective kinase inhibitor, for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received a prior ROS1 kinase inhibitor. The approval, granted ahead of the original 18 September 2026 target action date, follows Breakthrough Therapy and Orphan Drug Designations.
According to GSK, approval is based on the single-arm phase I/II ARROS-1 trial (n=117), which showed a 44% objective response rate and 6- and 12‑month duration-of-response rates of 82% and 69%. In the pooled safety population (n=446), common adverse reactions (≥15%) included oedema, peripheral neuropathy, constipation, fatigue and dyspnoea. Jideytro is GSK's first approved lung cancer medicine and part of the portfolio acquired with Nuvalent, alongside additional lung cancer assets in development.
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.