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 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.

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

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

The following is a summary of “Comparative safety of oral Janus kinase inhibitors versus dupilumab in patients with atopic ...

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

The following is a summary of “Integrative epidemiology and immuno-transcriptomics uncover a risk and potential mechanism for ...

More than 1,000,000 patients are currently being treated with Dupixent globally.1 Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date ...

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

for Dupixent ® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine ...