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Dupixent, Regeneron and FDA

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.

Benzinga.com · 3d

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.

MarketWatch · 3d

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.

Business Insider · 3d

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 activityMore than 300,000 people in the U.S.

Investor's Business Daily on MSN1mon

Regeneron And Sanofi Snag Their $6 Billion-Potential COPD Approval For Dupixent

Regeneron announced Friday that the company won Food and Drug Administration approval for Dupixent in chronic obstructive .

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 ...

pharmaphorum5d

Dupixent delivers in two skin disease trials

Sanofi and Regeneron have celebrated a pair of positive clinical trials in inflammatory skin disorders with blockbuster immunology therapy Dupixent that could both lead to new indications for the ...

Benzinga.com5d

Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease

The BOREAS Phase III trial showed DUPIXENT reduced exacerbations by 30% and improved lung function by 160 mL at 52 weeks.

Managed Healthcare Executive4d

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 ...

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