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: Paris Monday, November 18, 2024, 11:00 Hrs [IST] The US Food and Drug Admin ...

Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...

Paris: Sanofi and Regeneron has announced that the US Food and Drug Administration (FDA) has accepted for review the ...

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 ...

The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore ...

French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...

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

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 ...

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...