GSK News

Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma

GSK

PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. The FDA approval of Exdensur is based on data from the SWIFT-1 and SWIFT-2 phase III trials. In these studies, depemokimab demonstrated sustained exacerbation reduction with two doses per

December 17, 2025
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IBAT Inhibitors Market Witnesses Strong Growth During the Forecast Period (2025-2034) Owing to the Rising Demand for Rare Cholestatic Liver Disease Therapies | DelveInsight

GSK

The market for IBAT inhibitors is projected to experience significant growth in the near future, fueled by the rising incidence of genetic disorders, a strong pipeline of clinical trials, and growing regulatory approvals. Leading companies such as GlaxoSmithKline, Mirum Pharmaceuticals,...

August 11, 2025Market
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of GSK plc - GSK

GSK

NEW YORK, Aug. 11, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of GSK plc ("GSK" or the "Company") (NYSE: GSK). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns...

August 11, 2025Lawsuits
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STUDENTS STEP INTO THE ROLE OF ATHLETIC TRAINERS, CARDIOLOGISTS, DIETITIANS, AND MORE WITH FREE SUMMER SCIENCE PROGRAM!

GSK

GSK Science in the Summer™ Unveils New 2025 Theme: Be A Health Scientist! PHILADELPHIA, June 18, 2025 /PRNewswire/ -- GSK Science in the Summer™, a nationwide science program for students in grades 2 through 6, has announced a new theme for 2025: Be a Health Scientist! The 100% free STEM...

GSK announces the Linked by Lupus: Optimal Care Initiative to help support individuals with lupus in the US

GSK

PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced the launch of the Linked by Lupus: Optimal Care Initiative to help support individuals impacted with lupus, particularly systemic lupus erythematosus (SLE) and lupus nephritis (LN). “Too many people living with lupus face delays in diagnosis and disconnects in care,” said Court Horncastle, Senior Vice President at GSK. “With this initiative, we’re proud to support the organizations working within local communities to improve

Sagimet's Partner Achieves Positive Results With Oral Acne Drug In Phase 3 Trial In China, Stock Jumps

GSK

Denifanstat showed positive Phase 3 results in acne, meeting all goals with strong safety, as Sagimet pushes ahead with a second FASN inhibitor trial.

June 4, 2025
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Why Is Lyra Therapeutics Stock Surging Over 400% On Monday?

GSK

Lyra's LYR-210 met key goals in a Phase 3 trial for chronic rhinosinusitis, showing early and sustained symptom relief with a favorable safety profile.

June 2, 2025
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Theravance Biopharma Secures $225M In Cash From GSK Deal, Bringing Total Trelegy Monetization Value To $1.525B

GSK

June 2, 2025
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Regeneron, Sanofi Stock Falls After Uneven Smoker's Lung Drug Data

GSK

Regeneron and Sanofi's COPD drug itepekimab cut exacerbations by 27% in one Phase 3 trial, while the second trial did not meet its main goal.

May 30, 2025
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Why Is GSK Partner Spero Therapeutics Stock Skyrocketing On Wednesday?

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GSK and Spero ended a Phase 3 trial early meeting efficacy goals in cUTIs, positioning its treatment as the first oral carbapenem in the U.S.

May 28, 2025
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Spero Therapeutics And GSK Announce The PIVOT-PO Phase 3 Study Of Tebipenem HBr Met Its Primary Endpoint And will Stop Early For Efficacy

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May 28, 2025
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GSK's Blenrep (Belantamab Mafodotin) Received Positive Opinion Form The EUs CHMP For Treatment Of Relapsed Or Refractory Multiple Myeloma In Adults Aged 60+

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May 23, 2025
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GSK Announces Approval Of Nucala By US FDA For Use In Adults With Chronic Obstructive Pulmonary Disease

GSK

May 22, 2025
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GSK To Buy Phase-3 Ready Liver Disease Drug For Up To $2 Billion

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GSK acquires Boston Pharmaceuticals' efimosfermin for up to $2 billion, targeting liver diseases like MASH and ALD.

May 14, 2025
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GSK To Expand Liver Disease Portfolio With $1.2B Acquisition Of Boston Pharmaceuticals' Efimosfermin, Targeting 2029 Launch

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May 14, 2025
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iTeos Stock Soars Despite Trial Setback On Liquidation Buzz And Solid Cash Pile

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iTeos ends belrestotug program with GSK after Phase 2 trial fails to meet key survival goals; company explores strategic options to boost shareholder value.

May 13, 2025
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iTeos Reports Topline Interim Results From GALAXIES Lung-201 Study Of Belrestotug + Dostarlimab In First-Line, PD-L1 High Non-Small Cell Lung Cancer Patients; Did Not Meet Established Criteria For Clinically Meaningful Improvements In Progression Free Sur

GSK

May 13, 2025
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GSK Announced Results From GLISTEN Phase 3 Trial Of Linerixibat In Adults With Cholestatic Pruritus And PBC, A Rare Autoimmune Liver Disease. The Full Data Were Presented In A Late-breaker Oral Presentation At The EASL Congress 2025

GSK

May 8, 2025
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Britain's GSK Asserts It Is 'Well Positioned' To Mitigate Potential Tariffs After Strong Q1 Cancer And HIV Drug Sales

GSK

GSK beat Q1 estimates with $9.46 billion in sales and $1.13 EPS, driven by strong Specialty Medicines and meningitis vaccine performance.

April 30, 2025
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GSK Raises FY2025 Adj EPS Guidance from $4.18-$4.26 to $4.25-$4.59 vs $4.36 Est; Raises FY2025 Sales Guidance from $40.07B-$40.85B to $40.68B-$42.71B vs $32.61B Est

GSK

April 30, 2025
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GSK Affirms Its FY25 Guidance And Expects Its Turnover To Increase Between 3%-5% And Core Operating Profit To Increase Between 6%-8%. Core EPS Is Expected To Increase Between 6%-8%

GSK

April 30, 2025
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GSK Q1 Adj. EPS $1.13 Beats $1.04 Estimate, Sales $9.46B Beat $7.46B Estimate

GSK

April 30, 2025
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US Advisory Panel Votes To Expand Recommendation For Pfizer, GSK's RSV Vaccines For Older Adults Below 60 Years

GSK

CDC panel expands Pfizer and GSK RSV vaccine use to high-risk adults 50–59, building on earlier recommendations for older populations.

April 17, 2025
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UK Becomes First Country To Authorize Blenrep In Two Combo Regimens

GSK

GSK's Blenrep approved in the U.K. for multiple myeloma after strong phase 3 data showing improved survival in DREAMM-7 and DREAMM-8 trials.

April 17, 2025
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GSK Announces Health Canada Expands Jemperli Plus Chemotherapy Approval To All Adult Patients With Primary Advanced Or First Recurrent Endometrial Cancer, As The First And Only Immuno-Oncology-Based Treatment To Show An Overall Survival Benefit For These

GSK

April 17, 2025
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GSK Plc Reveals That CDC Advisory Panel Recommends PENMENVY for Inclusion in Adolescent Meningococcal Vaccination Schedule

GSK

April 16, 2025
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Watching GSK; Shares Move Higher, Goldman Sachs Suggesting Arexvy To Be Expanded By CDC; Our Read Of The Slides Suggests The ACIP Voting To Expand Its Recommended Population For Arexvy To Those Aged 50-59 'At-Risk' Is Likely

GSK

April 14, 2025
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ABL Bio Announced A Worldwide Licensing Agreement With GSK To Develop Medicines For Neurodegenerative Diseases By Utilizing ABL Bio's Blood-brain Barrier Shuttle Platform, Grabody-B, ABL Bio Will Receive Up To £2.075B Including £77.1M In Upfront And Near-

GSK

April 7, 2025
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New Study Shows Shingles Vaccine Linked To 20% Lower Dementia Risk, GSK Stock Pops

GSK

A study of over 280,000 adults found that the shingles vaccine reduced dementia risk by 20%, with a stronger effect in women.

April 3, 2025
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'U.S. Prosecutors Probe Tip About Timing Of Pfizer Vaccine; Claim Came To The U.S. Attorney's Office In Manhattan Via Pfizer Rival GSK' - WSJ

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March 26, 2025
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FDA Approves GSK's Oral Antibiotic For Urinary Tract Infections For Females Aged 12 Years And Older

GSK

The FDA approved GSK's Blujepa for uncomplicated UTIs in female adults and pediatric patients, with phase 3 trials showing strong efficacy vs. nitrofurantoin.

March 26, 2025
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ViiV Healthcare Announces Reimbursement For APRETUDE For HIV-1 Pre-Exposure Prophylaxis Under The Non-Insured Health Benefits Program

GSK

March 26, 2025
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GSK Gets FDA Approval Of Blujepa For Treatment Of Uncomplicated Urinary Tract Infections In Female Adults And Adolescents; This Is The First In A New Class Of Oral Antibiotic Treatment For uUTIs In Over 20 Years

GSK

March 25, 2025
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The European Medicines Agency Has Accepted For Review Its Application To Expand The Use Of GSK's Nucala (Mepolizumab) As An Add-on Maintenance Treatment For Patients With Chronic Obstructive Pulmonary Disease With An Eosinophilic Phenotype

GSK

March 24, 2025
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'U.S. Measles Cases In 2025 Have Already Surpassed The Total For The Entire Year Of 2024' - Bloomberg

GSK

March 14, 2025
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GSK, Pfizer's ViiV Healthcare Shows Strong HIV Viral Suppression In Latest Study

GSK

ViiV Healthcare's EMBRACE study shows VH109 with CAB LA effectively suppresses HIV. The company also reports promising early data on VH184 and VH499 therapies.

March 12, 2025
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ViiV Healthcare Announces Findings From The Company's EMBRACE Phase IIb Study; N6LS Maintains Viral Suppression In Long-acting Treatment Of HIV

GSK

March 12, 2025
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Cancer-Focused Zymeworks' Q4 Earnings Miss Expectations, Reprioritize Resources To Focus On ZW251

GSK

Zymeworks shifts focus to ZW251 for liver cancer, delaying ZW220. Q4 revenue and earnings missed estimates. GSK milestone adds $14M to cash reserves.

March 6, 2025
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ViiV Healthcare Announces That Quebec Has Become The First Province To Publicly Reimburse APRETUDE For Pre-Exposure Prophylaxis To Reduce The Risk Of Sexually Acquired HIV-1 Infection In At-Risk Individuals Who Are HIV-1 Negative

GSK

March 5, 2025
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GSK's Once-Daily Inhalers For Smoker's Lung Has Potential Benefits: Independent Organization Report

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ICER assessed GSK's COPD inhalers, Trelegy Ellipta and Breo Ellipta, for Medicare price negotiations, highlighting their once-daily dosing and comparable net health benefits.

March 4, 2025
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GSK's Twice-Yearly Depemokimab Reduces Nasal Polyp Size, Goes Under FDA Review

GSK

FDA reviews GSK depemokimab for asthma and CRSwNP, with a decision expected by December 2025. Phase 3 data shows improvements.

March 3, 2025
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The FDA Has Accepted For Review GSK's Biologics License Application For The Use Of Depemokimab In Two Indications, The Prescription Drug User Fee Act Date Is 16 December 2025

GSK

March 3, 2025
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On Saturday, GSK Announced Full Results From ANCHOR-1 and ANCHOR-2 Phase 3 Trials Assessing The Efficacy And Safety Of Depemokimab Versus Placebo In Adults With Chronic Rhinosinusitis With Nasal Polyps

GSK

March 3, 2025
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Sensodyne Toothpaste Maker Haleon Expects Profit To Be Weighted Towards Second Half Of 2025

GSK

Haleon posted £11.23B in FY24 revenue, with 5% organic growth. 2025 guidance expects 4-6% organic growth, with profit gains weighted to the second half.

February 27, 2025
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U.S. Agriculture Secretary Brooke Rollins Says USDA Will Invest Up To $1B In Strategy To Curb Avian Flu; USDA Is Not Yet Authorizing Use Of Bird Flu Vaccines For Chickens

GSK

February 26, 2025
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The China National Medical Products Administration Has Accepted For Review GSK's New Drug Application For Nucala (Mepolizumab) As An Add-on Maintenance Treatment For Patients With Chronic Obstructive Pulmonary Disease With An Eosinophilic Phenotype

GSK

February 20, 2025
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FDA Approves GSK's 5-in-1 Meningococcal Vaccine For Adolescents Ahead Of CDC Advisory Committee Vote Meeting Next Week

GSK

GSK's Penmenvy wins FDA approval to protect against five meningococcal serogroups. The CDC panel will vote on usage recommendations on Feb. 26.

February 18, 2025
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