GSK plc

Sep 22, 2026

GSK Canada and the pan-Canadian Pharmaceutical Alliance sign Letter of Intent for Blenrep for the treatment of relapsed or refractory multiple myeloma

GSK Canada has finalized a Letter of Intent with the pan-Canadian Pharmaceutical Alliance for Blenrep, a treatment for relapsed or refractory multiple myeloma. This agreement aims to secure public drug plan coverage, allowing eligible patients access to this new therapeutic option. The move is seen as a significant step towards improving treatment accessibility for patients facing this complex disease.

Jul 22, 2026

Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer

GSK has received FDA approval for Jideytro (zidesamtinib), a selective ROS1 inhibitor, for adults with previously treated ROS1-positive non-small cell lung cancer (NSCLC). This approval is based on the ARROS-1 phase I/II trial, which showed significant and durable responses in patients. Jideytro is GSK's first lung cancer treatment and aims to improve patient outcomes by addressing resistance mutations and brain metastases.

Jun 17, 2026

Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)

GSK's Utebzi (tebipenem pivoxil) has been approved in the United States for the treatment of complicated urinary tract infections (cUTIs) in adults. This approval marks a significant advancement in antibiotic therapies, providing healthcare professionals with a new option to manage these infections. The introduction of Utebzi is expected to enhance patient care in this area.

May 28, 2026

GSKPhases

GSK, Ionis’ hepatitis B functional cure effectively eliminates virus in nearly 20% of patients

GSK and Ionis Pharmaceuticals reported that their investigational drug bepirovirsen led to a functional cure in nearly 20% of chronic hepatitis B patients in Phase 3 studies. The results showed a higher success rate in patients with low viral activity. The FDA has granted priority review for bepirovirsen, with regulatory decisions expected soon.

Apr 30, 2026

GSKPhases

GSK-partnered Alector hit with third neuro failure as Alzheimer’s asset disappoints

GSK and Alector have halted the Phase 2 study of nivisnebart for Alzheimer's due to lack of efficacy. This failure marks Alector's third setback in recent years, following the discontinuation of another asset, latozinemab. Despite these challenges, analysts remain hopeful about Alector's future prospects and its new ABC platform aimed at neurodegenerative diseases.

Apr 3, 2026

Trump Hits Drugmakers With 100% Tariff but Carve-outs Soften the Blow

The Trump administration has imposed a 100% tariff on imports of patented pharmaceuticals, effective in 120 days for large companies and 180 days for smaller ones. While some companies have secured exemptions through agreements, others like GSK and Johnson & Johnson are still facing tariffs. Analysts suggest that carve-outs for certain drugs may lessen the overall impact on the industry, but concerns remain regarding the potential harm to smaller biotech firms.

Mar 9, 2026

FDA clears repurposed GSK drug for ultra-rare brain disease instead of autism

The FDA approved GSK's Wellcovorin for treating cerebral folate deficiency, a rare neurological syndrome, instead of autism as initially suggested. The decision highlights the agency's commitment to rare diseases but contrasts with earlier claims of broader benefits for autistic children.

Feb 18, 2026

GSKPhases

GSK’s AREXVY Associated With Reductions in Certain RSV-Related Risks Including Heart Attack, Stroke and Severe Flare-Ups of COPD and Asthma, Real World Study Shows

GSK presented new data at RSVVW'26 showing that its RSV vaccine, AREXVY, significantly reduces the risk of RSV-related hospitalizations and associated cardiovascular events in adults aged 60 and older. The study demonstrated a 75.6% effectiveness against hospitalization and notable reductions in severe COPD and asthma flare-ups. These findings contribute to the understanding of RSV's impact on health outcomes.

Jan 27, 2026

Big Pharma Tight-Lipped on Details of API Stockpile Deals

GSK, along with Bristol Myers Squibb and Merck, has committed to contribute active pharmaceutical ingredients to the U.S. Strategic Active Pharmaceutical Ingredients Reserve as part of a broader initiative to enhance supply chain resilience. While the agreements are framed as a means to ensure adequate supplies in emergencies, many specifics remain undisclosed, including the origins of the donated materials. This lack of transparency raises questions about the effectiveness and reliability of the initiative.

Jan 21, 2026

GSK Awards $2M in COiMMUNITY Initiative Grants to Help Close Vaccination Gaps, Commits $3M for 2026

GSK has announced the recipients of its COiMMUNITY Initiative grants, awarding $2 million to 16 organizations aimed at improving vaccination rates in the U.S. The initiative, now in its third year, will also allocate $3 million in 2026 for projects focused on vaccine communication and delivery. Various organizations, including The J.A.M.I.E. Group and Immunize Colorado, will utilize these funds to address barriers to immunization.

Jan 21, 2026

GSK Announces Recipients of Linked by Lupus: Optimal Care Initiative Grants Nearing $1 Million

GSK has announced the recipients of the Linked by Lupus: Optimal Care Initiative grant, awarding nearly $1 million to support organizations focused on improving the lives of those affected by lupus. The initiative aims to enhance awareness, diagnosis, and treatment options for lupus patients. Thirteen grantees were selected for their innovative community-led programs. GSK emphasizes its commitment to fostering a connected lupus community.

Dec 22, 2025

Samsung Biologics Expands U.S. Manufacturing Capabilities with Strategic Acquisition of Human Genome Sciences from GSK

Samsung Biologics has announced the acquisition of Human Genome Sciences from GSK, marking its first U.S.-based manufacturing site in Rockville, Maryland. This strategic acquisition, valued at $280 million, aims to enhance production capacity and support a resilient supply chain for critical biologic medicines. The deal is expected to close by the end of Q1 2026, retaining over 500 employees at the site.

Dec 11, 2025

GSK’s Blujepa Opens First New Class of Gonorrhea Antibiotic in More Than 30 Years

GSK's Blujepa has received FDA approval for treating uncomplicated urogenital gonorrhea, marking the first new antibiotic class for this infection in over 30 years. The drug shows a high success rate and no serious side effects, addressing a significant public health threat due to rising antibiotic resistance.

Oct 23, 2025

FDA clears return of GSK’s once-withdrawn multiple myeloma drug

The FDA has approved GSK's multiple myeloma drug Blenrep, allowing its return to the market after being withdrawn. The approval comes with conditions, permitting its use with Velcade but not Pomalyst. GSK views this as a significant milestone, despite previous challenges and competition in the market.

May 22, 2025

Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD) | GSK

Nucala (mepolizumab) has been approved by the FDA as an add-on treatment for adults with inadequately controlled COPD and an eosinophilic phenotype, based on positive trial results showing significant reduction in exacerbations.

Mar 25, 2025

Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older | GSK

The US FDA has approved Blujepa (gepotidacin) for treating uncomplicated urinary tract infections in female adults and pediatric patients. This first-in-class antibiotic shows promise against recurrent infections and has demonstrated efficacy in pivotal trials compared to existing treatments.

Aug 1, 2024

US FDA expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit | GSK

The FDA has expanded the approval of Jemperli (dostarlimab) plus chemotherapy for adult patients with primary advanced or recurrent endometrial cancer, showing a 31% reduction in risk of death. This treatment now includes the majority of endometrial cancer cases, providing a significant survival benefit.

Apr 5, 2024

ViiV Healthcare announces U.S. FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV

ViiV Healthcare announced FDA approval of Dovato for adolescents aged 12 and older living with HIV. This marks the first oral, two-drug, single-tablet regimen for this demographic, aiming to improve treatment options for young people with HIV.

Feb 9, 2023

US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer | GSK

The FDA has granted full approval for Jemperli to treat patients with recurrent or advanced mismatch repair-deficient endometrial cancer, based on positive outcomes from the GARNET trial. The treatment shows a significant overall response rate and duration of response, although some adverse reactions were noted.

Jul 26, 2022