The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for chronic spontaneous urticaria on April 18, 2025.

Aging is undoubtedly a natural part of life, and while some embrace what time does to their skin, others might look for a ...

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 ...

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License ...

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.

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 ...

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

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

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