The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

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

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...

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

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 ...

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 ...

The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.

Corvus Pharmaceuticals Inc (CRVS) progresses with promising trials and designations, despite reporting a significant net loss for the quarter.

After a long road that included a three-month delay as the agency pushed for additional data, the US FDA has approved Sanofi and Regeneron's Dupixent (dupilumab) for COPD - as has China's National ...

Sanofi and Regeneron’s immunology juggernaut Dupixent is on the brink of another ... and that situation contrasts with the US, where the FDA has just delayed the timeline for its verdict on ...

Eli Lilly’s Ebglyss (lebrikizumab-lbkz) showed improvement in skin clearance and itch relief for most patients with ...