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 ...

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 ...

The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in ...

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

Good morning and welcome to the Regeneron Pharmaceuticals ... primarily driven by higher Sanofi collaboration revenues reflecting the continued strong performance of Dupixent, continued growth ...

Blockbuster immunology drug Dupixent so far generates 80% of its sales in the US, and Regeneron is beginning to book a significant profit share on the drug from partner Sanofi. Proposals for ...

TARRYTOWN, N.Y., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals ... higher profits associated with an increase in Dupixent sales. Sanofi collaboration revenue in the third quarter ...

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 ...

Sanofi attributed its double-digit growth to growth in vaccines, particularly its latest flu jab. Another major revenue contributor was Dupixent, the company's COPD treatment, whose sales surged ...