GSK plc

Jul 22, 2026

Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor,...

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

LRA Congratulates GSK on FDA Approval of Benlysta® (belimumab) for Children with Lupus Nephritis

The FDA has approved belimumab (Benlysta®) as the first treatment for children aged 5 to 17 with lupus nephritis, marking a significant advancement in pediatric lupus care. The Lupus Research Alliance celebrates this milestone, highlighting their role in funding the research that contributed to the drug's development.

Mar 30, 2022

ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV | GSK

ViiV Healthcare has received FDA approval for Triumeq PD, the first dispersible single tablet regimen for children with HIV. This approval enhances treatment options for pediatric patients and reflects ViiV's commitment to developing age-appropriate formulations for young children living with HIV.

Dec 20, 2021

GSK's long-acting HIV shot approved for preventive use

The FDA has approved Apretude, a long-acting injectable medication for HIV prevention, marking a significant advancement in HIV treatment options. Developed by ViiV Healthcare, it aims to improve adherence among high-risk populations, although challenges like access and stigma remain.

Aug 17, 2021

GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors

GSK's JEMPERLI (dostarlimab-gxly) received FDA accelerated approval for treating adult patients with dMMR recurrent or advanced solid tumors. The approval is based on positive trial results, showing a 41.6% objective response rate and a median duration of response of 34.7 months, although continued approval depends on further clinical verification.

Jul 29, 2021

GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps | GSK

GSK announced FDA approval for Nucala (mepolizumab) as the first anti-IL-5 therapy for adults with chronic rhinosinusitis with nasal polyps. This approval offers a new treatment option for over 5 million affected patients, providing an alternative to surgery and addressing significant unmet medical needs.

Apr 22, 2021

FDA grants accelerated approval for GSKâs JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer | GSK

The FDA has granted accelerated approval for GSK's JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer, based on promising results from the GARNET study, which showed a 42% overall response rate and significant durability of response.

Apr 22, 2021

FDA grants accelerated approval for GSK's JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer

The FDA has granted accelerated approval for GSK's JEMPERLI (dostarlimab-gxly) to treat women with recurrent or advanced dMMR endometrial cancer. This approval is based on promising trial results, indicating a significant potential to improve treatment options for affected patients.

Jan 21, 2021

ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment | GSK

ViiV Healthcare announced FDA approval of Cabenuva, the first complete long-acting regimen for HIV treatment, allowing virologically suppressed adults to maintain viral suppression with only 12 dosing days per year. The approval is based on pivotal studies showing high patient preference and effectiveness compared to daily oral regimens.

Dec 16, 2020

FDA approves GSK's BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US

The FDA has approved GSK's BENLYSTA for treating adult patients with active lupus nephritis, marking it as the first medication for this condition. The approval is based on positive results from the BLISS-LN study, which showed significant improvements in patient outcomes.

Sep 9, 2020

Investor Relations - FDA Approves Trelegy Ellipta as the First Once-Daily Single Inhaler Triple Therapy for the Treatment of Both Asthma and COPD in the US - Innoviva

The FDA has approved Trelegy Ellipta as the first once-daily single inhaler triple therapy for asthma and COPD, providing a new treatment option for patients. This approval is based on positive study results showing improved lung function, marking a significant advancement in asthma management.

Jun 12, 2020

ViiV Healthcare announces US FDA approval of the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV | GSK

ViiV Healthcare announced FDA approval for Tivicay PD, the first dispersible tablet formulation of dolutegravir for children with HIV. This innovative treatment aims to improve access to life-saving medications for young patients, addressing significant barriers in paediatric HIV care.

Apr 29, 2020

FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status

The FDA has approved Zejula (niraparib) as the first once-daily PARP inhibitor for maintenance treatment in women with advanced ovarian cancer, regardless of biomarker status. This approval is based on positive results from the PRIMA study, which showed significant improvements in progression-free survival.

Apr 26, 2019

GSK receives US approval of Benlysta for intravenous use in children with lupus aged five years and above

GSK's Benlysta has received FDA approval for intravenous use in children aged five and older with lupus, providing a new treatment option. The approval is based on a study showing improved disease activity in treated children compared to placebo, although some adverse events were noted.

Apr 8, 2019

GSK’s HIV drug Dovato gets FDA approval - PharmaTimes

GSK's Dovato has received FDA approval as the first two-drug complete regimen for HIV-1 treatment in patients with no prior antiretroviral therapy. The approval is based on studies showing its effectiveness comparable to traditional three-drug regimens, offering a simpler and potentially safer treatment option.

Sep 7, 2018

GSK receives complete response letter from US FDA for use of mepolizumab in COPD patients | GSK

GSK received a complete response letter from the US FDA for its application of mepolizumab as an add-on treatment for COPD, indicating that additional clinical data is needed for approval. GSK plans to collaborate with the FDA on the next steps.

Jul 20, 2018

GSK secures US approval of new malaria drug

GSK has received FDA approval for Krintafel, a new treatment for Plasmodium vivax malaria, the first in 60 years. The drug will be marketed at a not-for-profit price in malaria-endemic countries, with plans for further global approvals.

May 17, 2018

GSK receives US approval of Arnuity Ellipta for use in children from 5 years old who suffer from asthma | GSK

GSK has received FDA approval for Arnuity Ellipta, a once-daily inhaled corticosteroid for asthma maintenance in children aged 5 to 11. The approval follows a pivotal study showing significant improvements in lung function, addressing a critical need for effective treatments in this age group.

Dec 12, 2017

GSK achieves approval for Nucala (mepolizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) for adults in the US

GSK's Nucala (mepolizumab) has received FDA approval as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA) in adults. The approval is based on positive results from the MIRRA study, demonstrating significant efficacy and safety compared to placebo.

Nov 21, 2017

Juluca® (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill - a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection

Juluca® has been approved by the FDA as the first once-daily, single-pill, 2-drug regimen for the maintenance treatment of virologically suppressed HIV-1 infection in adults. This approval is based on pivotal phase III trials demonstrating its efficacy and safety compared to traditional regimens.

Oct 26, 2017

The ASCO Post

The FDA approved intravenous rolapitant (Varubi) for preventing delayed nausea and vomiting in cancer chemotherapy. Clinical trials showed significant efficacy in reducing CINV episodes, offering a new treatment option for patients experiencing these debilitating side effects.

Sep 18, 2017

Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US | GSK

The FDA has approved Trelegy Ellipta, the first once-daily single inhaler triple therapy for COPD, enhancing treatment options for patients. This approval marks a significant milestone for GSK and Innoviva, with plans for further regulatory applications in other countries.

Jul 20, 2017

GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus

GSK has received FDA approval for a new self-injectable formulation of Benlysta for treating adult patients with systemic lupus erythematosus. This marks the first subcutaneous treatment option, allowing patients to self-administer the medication at home, enhancing convenience and accessibility.

Jan 12, 2017

TESARO Receives Complete Response Letter for Rolapitant IV from U.S. FDA

TESARO announced that the FDA issued a Complete Response Letter for rolapitant IV, requesting additional information but raising no concerns about its efficacy or safety. The company is working to address the FDA's questions and aims for approval in the first half of 2017.

Apr 30, 2015

FDA approves BREO® ELLIPTA® for the treatment of adults with asthma in the US

The FDA has approved BREO ELLIPTA for the once-daily treatment of asthma in adults aged 18 and older. This approval offers new treatment options for asthma management, although it is not approved for acute bronchospasm and requires caution in younger patients.

Aug 22, 2014

Pfizer, GSK's Viiv Healthcare nabs FDA approval for 3-in-1 HIV drug

Pfizer and GSK's Viiv Healthcare received FDA approval for Triumeq, a three-in-one HIV drug. This is the first dolutegravir-based fixed-dose combination, showing improved efficacy over Gilead's Atripla in clinical trials. The drug is expected to gain European approval soon.

Aug 20, 2014

GSK receives FDA approval for Arnuity™ Ellipta® (fluticasone furoate) in the US for the treatment of asthma

GSK has received FDA approval for Arnuity™ Ellipta® (fluticasone furoate), a once-daily inhaled corticosteroid for asthma maintenance treatment in patients aged 12 and older. This marks a significant addition to GSK's respiratory portfolio.

Apr 30, 2014

GSK receives approval for Incruse™ Ellipta® (umeclidinium) in the US for the treatment of COPD

GSK has received FDA approval for Incruse Ellipta (umeclidinium), a once-daily treatment for COPD. This marks GSK's first anticholinergic monotherapy, aimed at improving treatment options for patients. Launch activities are expected to begin in Q4 2014.

Apr 15, 2014

GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeumâ¢ (albiglutide) | GSK

GSK announced FDA approval for Tanzeum (albiglutide), a once-weekly injection for type 2 diabetes, aimed at improving glycemic control. The approval follows extensive clinical trials and is expected to launch in the US in Q3 2014.

Dec 18, 2013

ANOROâ¢ ELLIPTAâ¢ approved as first once-daily dual bronchodilator for the treatment of COPD in the US | GSK

The FDA has approved Anoro Ellipta, the first once-daily dual bronchodilator for COPD treatment in the US. This approval marks a significant milestone for GlaxoSmithKline and Theravance, with launch activities anticipated in early 2014.

May 10, 2013

BREO™ ELLIPTA™ gains US approval for the treatment of COPD

BREO ELLIPTA has received FDA approval for the long-term treatment of COPD, offering a once-daily inhalation option to improve airflow and reduce exacerbations. The drug is expected to be available in the US by Q3 2013.

Dec 14, 2012

GSK receives FDA approval for raxibacumab anti-toxin for the treatment of inhalational anthrax

GSK has received FDA approval for raxibacumab, the first monoclonal anti-toxin for inhalational anthrax, to be used with antibacterial drugs. The approval is based on animal studies, with safety evaluated in adults. The drug aims to enhance biodefense against anthrax, although it has not been tested in children.

Jun 10, 2011

Valeant and GlaxoSmithKline Announce U.S. FDA Approval of Potiga™ (ezogabine)

Valeant Pharmaceuticals and GlaxoSmithKline announced FDA approval for Potiga™ (ezogabine) for treating partial-onset seizures in adults. The drug will be available in U.S. pharmacies by year-end, pending scheduling as a controlled substance. Clinical studies confirmed its efficacy, though it carries risks of urinary retention and other adverse reactions.

Apr 25, 2011

FDA Approves Lamictal®XR™ (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients

The FDA has approved Lamictal XR for conversion to monotherapy in patients 13 years and older with partial seizures. This new indication offers an additional treatment option, although safety and effectiveness as initial monotherapy have not been established.

Mar 9, 2011

GlaxoSmithKline and Human Genome Sciences announce FDA approval of Benlysta® (belimumab) for the treatment of systemic lupus erythematosus | GSK

The FDA has approved Benlysta® (belimumab) for treating systemic lupus erythematosus, marking the first new drug for this condition in over 50 years. While the approval is a significant advancement, there are limitations and safety concerns associated with its use.

May 29, 2009

GSK/Concert sign $1 billion deal, Lamictal XR approved - PharmaTimes

GSK has entered a $1 billion deal with Concert Pharmaceuticals to develop deuterium-modified drugs, enhancing metabolic properties. Additionally, the FDA approved GSK's Lamictal XR for epilepsy, showing significant seizure reduction in trials, despite a decline in Lamictal sales.

May 8, 2009

FDA Approves GlaxoSmithKline's Lamictal(R) ODT(TM) Orally Disintegrating Tablets

The FDA has approved GlaxoSmithKline's Lamictal ODT, an orally disintegrating tablet for patients with epilepsy and bipolar disorder, providing a new alternative for those who have difficulty swallowing. It will be available in various strengths starting in July.

Jun 13, 2008