Dupixent, sBLA

FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria
Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their resubmitted supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of chronic spontaneous urticaria (CSU).
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.
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
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)
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.
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,
Benzinga.com5d
Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease
After years of limited advancements in chronic obstructive pulmonary disease (COPD) treatment, patients now have new ...
Managed Healthcare Executive3d
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 ...
News Medical on MSN2d
Study focuses on COPD progression in younger populations
Researchers are exploring how small airway abnormalities in younger smokers could help identify who is at risk of developing ...