Dupixent, Regeneron and FDA

FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease
Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a decision expected by April 2025.
Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License
Regeneron, Sanofi Get New FDA Review of Dupixent for CSU
The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in CSU, which causes sudden and debilitating hives and recurring itch.
Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not
EMA approves Sanofi/Regeneron’s Dupixent for young EoE patients
The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and adults with EoE. Sanofi research and development head and e
Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm
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FDA Sets Date For Resubmitted Dupixent in Inflammatory Skin Disease
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
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Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease
This expansion positions Dupixent as the first targeted therapy for COPD, a significant leap in treating this progressive ...
2 Top Growth Stocks to Buy on the Dip
Has something changed regarding Eli Lilly or Regeneron's thesis, or is the recent dip an excellent opportunity to invest in ...
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Ebglyss Shows Improvement in Atopic Dermatitis Patients Who Stopped Dupixent
Eli Lilly’s Ebglyss (lebrikizumab-lbkz) showed improvement in skin clearance and itch relief for most patients with ...
Citi initiates coverage on 5 new biotech stocks
Citigroupa expanded its biotech coverage on Wednesday, adding five more stocks to the roster including Amgen (NASDAQ:AMGN), ...
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Dupixent® (dupilumab) Approved in the European Union as the First and Only Medicine for Young Children with Eosinophilic Esophagitis
TARRYTOWN, N.Y. and PARIS, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved Dupixent ...
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AstraZeneca, Amgen Claim Late-Stage Win in Chronic Rhinosinusitis but Analyst Flags ‘Regulatory Risk’
The companies did not provide detailed data for Tezspire, however, and William Blair’s Matt Phipps said in a note he does not ...