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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.
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Dupixent® (dupilumab) Recommended for EU Approval by the CHMP for the Treatment of Eosinophilic Esophagitis
12/16/2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent® (dupilumab) in the European Union (EU) to treat adults and adolescents with eosinophilic esophagitis (EoE).
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Press Release: Dupixent® (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis
12/16/2022
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent® (dupilumab) in the European Union (EU) to treat adults and adolescents with eosinophilic esophagitis (EoE).
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Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Prurigo Nodularis
12/15/2022
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has expanded the marketing authorization for Dupixent® in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
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Press Release: Dupixent® (dupilumab) approved by European Commission as the first and only targeted medicine indicated for prurigo nodularis
12/15/2022
The European Commission has expanded the marketing authorization for Dupixent® in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
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Kymera and Sanofi shared positive results for an IRAK4 degrader for hidradenitis suppurativa and atopic dermatitis.
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Janssen (Johnson & Johnson) is no longer in the running to acquire rare disease player Horizon Therapeutics, the company announced Saturday. This leaves Amgen and Sanofi at the bidding table.
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Regeneron ESMO IO Presentations Highlight Potential of Fianlimab and Libtayo® (cemiplimab) in Multiple Solid Tumor Types
12/1/2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2022 from December 7 to 9 in Geneva, Switzerland.
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Evkeeza® (evinacumab-dgnb) sBLA for Children with Ultra-rare Inherited Form of High Cholesterol Accepted for FDA Priority Review
11/30/2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Evkeeza® (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH).
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In a volatile year, marked with challenges, BioSpace is taking a pause to reflect on the many “wins” in biopharma.
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Libtayo® (cemiplimab) Approved by the European Commission as the First Immunotherapy in Second Line Recurrent or Metastatic Cervical Cancer Irrespective of PD-L1 Expression Level or Tumor Histology
11/22/2022
Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or metastatic cervical cancer, with Libtayo reducing the risk of death by 31% compared to chemotherapy during the study.