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Sanofi and Regeneron’s Dupixent (dupilumab) met its primary and all secondary endpoints in the Phase III BOREAS trial, significantly reducing severe exacerbations in COPD.
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Dupixent® (dupilumab) Demonstrates Potential to Become First Biologic to Treat COPD by Showing Significant Reduction in Exacerbations in Pivotal Trial
3/23/2023
Regeneron Pharmaceuticals, Inc. and Sanofi announced the primary and all key secondary endpoints were met in a Phase 3 trial evaluating the investigational use of Dupixent® compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease and evidence of type 2 inflammation.
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Press Release: Dupixent® demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial
3/23/2023
The primary and all key secondary endpoints were met in a Phase 3 trial evaluating the investigational use of Dupixent® compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease and evidence of type 2 inflammation.
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FDA Approves First-in-class Evkeeza® (evinacumab-dgnb) for Young Children with Ultra-rare Form of High Cholesterol
3/22/2023
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has extended the approval of Evkeeza® (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH).
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Dupixent® (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old with Severe Atopic Dermatitis
3/21/2023
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has approved Dupixent® in the European Union to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy.
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Press Release: Dupixent® (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis
3/21/2023
The European Commission has approved Dupixent® in the European Union to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy.
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Dupixent® (dupilumab) Late-Breaking Data at AAD Show Significant Improvements in Signs and Symptoms of Moderate-to-severe Atopic Hand and Foot Dermatitis
3/18/2023
Regeneron Pharmaceuticals, Inc. and Sanofi presented positive results from the clinical trial assessing Dupixent® in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis.
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Press Release: Dupixent® (dupilumab) late-breaking data at AAD show significant improvements in signs and symptoms of moderate-to-severe atopic hand and foot dermatitis
3/18/2023
Positive results from the clinical trial assessing Dupixent® in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented.
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Press Release: Dupixent® (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents accepted for FDA review
3/7/2023
The U.S. Food and Drug Administration has accepted, for review, the supplemental Biologics License Application for Dupixent® to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria that is not adequately controlled with the current standard of care, H1 antihistamine treatment.
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Dupixent® (dupilumab) Application for Treatment of Chronic Spontaneous Urticaria (CSU) in Adults and Adolescents Aged 12 Years and Older Accepted for FDA Review
3/7/2023
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application for Dupixent® to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria that is not adequately controlled with the current standard of care, H1 antihistamine treatment.
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Kevzara® (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients with Polymyalgia Rheumatica
2/28/2023
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
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Libtayo® (cemiplimab) in Combination with Chemotherapy Receives Positive CHMP Opinion for the Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)
2/24/2023
Regeneron Pharmaceuticals, Inc. announced the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo® in combination with platinum-based chemotherapy.
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Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults with Ultra-rare CHAPLE Disease Accepted for FDA Priority Review
2/21/2023
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for pozelimab as a treatment for adults and children as young as 1 year of age with CHAPLE disease (also known as CD55 deficiency with Hyperactivation of complement, Angiopathic thrombosis and Protein Losing Enteropathy or CD55-deficient protein-losing enteropathy).
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Sanofi’s global head of R&D, John Reed, is leaving his position to pursue another opportunity outside the company, the French multinational announced Monday.
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Regeneron Reports Fourth Quarter and Full Year 2022 Financial and Operating Results
2/3/2023
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2022 and provided a business update.
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Press Release : Strong sales performance and double digit EPS growth marking the achievement of the 2022 profitability milestone
2/3/2023
Strong sales performance and double digit EPS growth marking the achievement of the 2022 profitability milestone
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JPM Day 2: Highlights
1/10/2023
Stay on top of what's happening at JPM. BioSpace is covering all the key announcements all week. -
Libtayo® (cemiplimab) Approved in Japan for Advanced or Recurrent Cervical Cancer
12/23/2022
Regeneron Pharmaceuticals (NASDAQ: REGN) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Libtayo ® (cemiplimab) as monotherapy to treat patients with advanced or recurrent cervical cancer whose disease progressed after chemotherapy.
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Press Release: Positive Dupixent® (dupilumab) Phase 3 results in adults and adolescents with eosinophilic esophagitis published in the New England Journal of Medicine
12/21/2022
The New England Journal of Medicine has published results from a positive Phase 3 trial showing adults and adolescents treated with Dupixent® 300 mg weekly experienced significant improvements in signs and symptoms of eosinophilic esophagitis, which were sustained for up to one year.
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Positive Dupixent® (dupilumab) Phase 3 Results in Adults and Adolescents with Eosinophilic Esophagitis Published in the New England Journal of Medicine
12/21/2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the New England Journal of Medicine has published results from a positive Phase 3 trial showing adults and adolescents treated with Dupixent® (dupilumab) 300 mg weekly experienced significant improvements in signs and symptoms of eosinophilic esophagitis (EoE), which were sustained for up to one year.