Senate Investigation: Flovent Discontinuation Profited GSK, Harmed Kids
Pulling Flovent from the market in 2024 resulted in GSK profits and harm to pediatric asthma patients, according to a US Senate investigation reported by CNN.
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Senate Investigation: Flovent Discontinuation Profited GSK, Harmed Kids
Pulling Flovent from the market in 2024 resulted in GSK profits and harm to pediatric asthma patients, according to a US Senate investigation reported by CNN.
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RSV Vaccine Arexvy Gets Expanded Approval for At-risk Adults 18-49
The expanded approval means Arexvy is now indicated for all adults aged 60 and older, and adults aged 18–59 at increased risk for LRTD caused by RSV.
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FDA Approves First Flovent Generic for Asthma
The generic Flovent HFA (fluticasone propionate) inhalation aerosol is approved as a maintenance therapy for asthma in patients aged 4 years and older.
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FDA Approves Ultra-long-acting Biologic Depemokimab for Severe Asthma
Depemokimab is a twice-yearly administered monoclonal antibody approved for patients with severe asthma with an eosinophilic phenotype.
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GSK, Trump Administration Sign Agreement on Lower Drug Prices, Access to Respiratory Drugs
GlaxoSmithKline agreed to reduce costs for certain prescription drugs in the United States, after a direct request from the Trump administration.
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FDA Approves Mepolizumab for Adults with COPD
The US FDA has approved mepolizumab (Nucala) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.
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‘Alarming’ Overuse of Oral Corticosteroids in Severe Asthma Patients
A Canadian study found that 72% of patients with uncontrolled severe asthma were not on available biologic therapy, and 40% had four or more oral corticosteroid courses.
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Arexvy RSV Vaccine Shows Protection Over Three Seasons
Cumulative efficacy over three RSV seasons was clinically meaningful at 62.9% against RSV-LRTD after a single dose of the vaccine.
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GSK Clinches $1B Deal for Aiolos Bio and Its Investigational Asthma Therapy
GSK has agreed to acquire the startup biopharmaceutical company for $1 billion to access its investigational asthma treatment, AIO-001, ready to enter phase 2 clinical development.
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FDA Panel to Convene to Review Promising RSV Vaccine Candidates
The FDA accepted Biologics License Applications and granted priority review for both Pfizer and GSK’s RSV older adult vaccine candidates last year following positive data from phase 3 trials.
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GSK Sued Over Asthma Inhaler ‘Scheme’
Angling to block generics of Ventolin and Arnuity Ellipta, GSK for decades has “schemed” the FDA drug-device approval system to shield its asthma inhalers with patents and regulatory exclusivity, according to a proposed class-action complaint.
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Breo Ellipta Gets FDA Approval for COPD
GlaxoSmithKline and Theravance Inc’s Breo Ellipta, an inhaled long-term, once-daily treatment for airflow obstruction in COPD patients, has received FDA approval.
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