Sanofi US
Cambridge
Massachusetts
United States
200 articles about Sanofi US
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FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis
2/10/2022
FDA accepts Dupixent® for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis
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The FDA's decision is based on favorable results from Sanofi's Phase III CARDINAL trial, a 26-week open label, single arm study on 24 CAD patients.
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CHMP Recommends Approval of Dupixent® (dupilumab) for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation
1/31/2022
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the EMA's CHMP has adopted a positive opinion, recommending to extend the approval of Dupixent® in the EU to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide who are inadequately controlled on two maintenance therapies.
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Regeneron and Sanofi Provide Regulatory Update on Libtayo® (cemiplimab-rwlc) in Advanced Cervical Cancer
1/28/2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo ® (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.
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Second positive Phase 3 Dupixent® (dupilumab) trial confirms significant improvements for patients with prurigo nodularis
1/19/2022
A second Phase 3 trial evaluating Dupixent® in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease, met its primary and key secondary endpoints, showing it significantly reduced itch and skin lesions compared to placebo at 24 weeks in this investigational setting.
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Denali Therapeutics announced that the FDA had placed a clinical hold on the IND application for DNL919 and would receive an official clinical hold letter from the agency in about 30 days.
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Sanofi will pay ABL $75 million upfront, and the latter is eligible to receive as much as $985 million down the line as development, regulatory, and commercialization milestones are met.
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Sangamo Announces Transition of SAR445136 Sickle Cell Disease Program From Sanofi to Sangamo
1/6/2022
Sangamo Therapeutics, Inc. today announced that Sanofi will be transitioning its rights and obligations related to SAR445136.
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Sangamo Therapeutics announced that Sanofi US was returning its rights to SAR445136 as it shifts its approach from personalized cell therapies to allogeneic off-the-shelf genomic approaches.
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When 2022 rolls around in a little more than a week, some Genentech employees will begin the new year in search of a new job.
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Takeda hoped that its experimental therapy could become the first FDA-approved treatment for EoE. However, the FDA wants the company to initiate another clinical study with TAK-721.
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Parkinson’s disease has been immensely challenging for biotech companies. A high rate of late-stage attrition in trials has led to a lack of approved therapies for the disease.
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Sciwind Biosciences Acquires Global, Exclusive Rights to Develop and Commercialize Sanofi's GIP Receptor Agonists for the Treatment of Metabolic Disease
11/30/2021
Sciwind Biosciences Co., Ltd. announced that it has signed a global, exclusive license agreement with Sanofi to develop and commercialize Sanofi's long-lasting glucose-dependent insulinotropic polypeptide receptor agonists, with the lead candidate currently under preclinical development.
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Respiratory Syncytial Virus has been around for a very long period now. But there was no vaccine yet. But, here's the first vaccine for RSV to shape the future.
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It’s not unusual for biopharma companies to end the year with a restructuring that includes job cuts. Here are some of these companies.
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Koneksa Broadens Multi-Year CNS Research Collaboration with Sanofi
11/3/2021
Koneksa today announced that Sanofi, one of the world's top biopharmaceutical companies, has extended the two companies' collaboration in central nervous system (CNS) clinical trials.
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Researchers found improvements in the study's co-primary endpoints in patient-reported measures of esophageal inflammation and difficulty swallowing.
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Skin health logged major wins this week after two companies announced positive clinical trial results.
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ReCode is aiming to advance its lead candidates for cystic fibrosis and primary ciliary dyskinesia (PCD).