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.

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

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

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

(RTTNews) - Sanofi announced that Beyfortus (nirsevimab) will be broadly available for babies born in Ontario, Quebec, Nunavut, Northwest Territories, and the Yukon this fall. The administration ...

The first high-speed mobile network, 3G, was launched in Australia in 2003 but has been overtaken by better and faster connections. While Vodafone began shutting down its 3G network between ...

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

With Ebglyss, 57% of patients in Week 16 and 60% in Week 24 who had previously been treated with dupilumab achieved EASI-75. The study’s primary endpoint was measured by at least a 75% ...

Sanofi (NASDAQ:SNY) shares gained on Friday after the French pharma giant exceeded analysts' estimates with its Q3 thanks mainly to earlier-than-anticipated vaccine sales and a 22% YoY rise in ...

Despite Merck & Co. homing in on approval for its infant respiratory syncytial virus (RSV) antibody clesrovimab, Sanofi—which last year won its own nod for its AstraZeneca-partnered RSV ...

who were previously treated with Sanofi SA (NASDAQ:SNY) / Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) Dupixent (dupilumab). The study’s primary endpoint was measured by at least a 75% improvement in ...