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Dupixent, Regeneron
FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
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.
FDA to Review Resubmitted Dupilumab sBLA for Chronic Spontaneous Urticaria
The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.
Sanofi, Regeneron's Dupixent SBLA Accepted For FDA Review To Treat Chronic Spontaneous Urticaria
French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration
Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU)
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines FDA decision expected by April 18,
Managed Healthcare Executive
18h
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 ...
Yahoo Finance
2d
Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease
Also Read:
Regeneron
’s
Dupixent
COPD Sales To Reach $20B By 2026, Analyst Sees Larger Addressable Market The condition ...
19h
Check Out What Whales Are Doing With REGN
Looking at options history for Regeneron Pharmaceuticals REGN we detected 8 trades. If we consider the specifics of each ...
1d
2 Top Growth Stocks to Buy on the Dip
2 Top Growth Stocks to Buy on the Dip was originally published by The Motley Fool ...
1d
Regeneron股价触及52周低点785.31美元
Regeneron Pharmaceuticals Inc. (REGN)股价已触及52周低点,交易价格为785.31美元。这一价格水平反映出过去一年来股价出现了0.43%的微小但显著下跌,表明这家以创新药物闻名的生物技术公司正处于整固期。投资者正密切关注该股在这一低点的表现,考虑公司的业绩以及可能影响未来几个月走势的潜在市场动向。 在其他近期新闻中,Regeneron Pharmaceutica ...
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