Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)-4 and IL-13 pathways, is currently ...

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 ...

The sBLA seeks approval for CSU in people aged 12 years and older whose disease is not adequately controlled with existing ...

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

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 ...

Abstract and Introduction Predicting and Establishing the Clinical Efficacy of a Histamine H Application ... inflammatory mechanisms of action of H 1-receptor antagonists and to predict their ...

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

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

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

The phase III LIBERTY-CUPID study C showed that among children and adults randomized to receive either dupilumab or placebo added to standard-of-care (SoC) H1 antihistamines, those receiving ...