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 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.
US FDA accepts for review the resubmission of sBLA for Dupixent to treat chronic spontaneous urticaria
US FDA accepts for review the resubmission of sBLA for Dupixent to treat chronic spontaneous urticaria: Paris Monday, November 18, 2024, 11:00 Hrs [IST] The US Food and Drug Admin
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.
Sanofi, Regeneron Dupixent sBLA accepted for USFDA review for chronic spontaneous urticaria
Paris: Sanofi and Regeneron has announced that the US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA)
Regeneron, Sanofi Get New FDA Review of Dupixent for CSU
Regeneron Pharmaceuticals and Sanofi said the U.S. Food and Drug Administration has accepted their resubmitted application seeking expanded approval of the blockbuster anti-inflammatory drug Dupixent for the inflammatory skin condition chronic spontaneous urticaria,
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
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Safety Profile of Oral JAK Inhibitors in AD Treatment
The following is a summary of “Comparative safety of oral Janus kinase inhibitors versus dupilumab in patients with atopic ...
Dupixent® (dupilumab) Approved in the European Union as the First and Only Medicine for Young Children with Eosinophilic Esophagitis
Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 ...