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 ...
Paris: Sanofi and Regeneron has announced that the US Food and Drug Administration (FDA) has accepted for review the ...
The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
The following is a summary of “Comparative safety of oral Janus kinase inhibitors versus dupilumab in patients with atopic ...
Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...
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 ...
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.
Eli Lilly’s Ebglyss (lebrikizumab-lbkz) showed improvement in skin clearance and itch relief for most patients with ...
Continued execution across all programs, including positive results up to nine months from APG777 Phase 1 trial that continue to support potential best-in-class profile On track to report Phase 2 Part ...