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

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

Ariel Investments, an investment management company, released its “Ariel Global Fund” third-quarter 2024 investor letter. A copy of the letter can be downloaded here. Despite significant volatility, ...

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

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

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

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

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

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 ...

Outside of Japan and the UAE, the safety and efficacy of Dupixent in CSU remain under evaluation. The potential new indication for CSU comes as Regeneron and Sanofi continue to expand Dupixent’s ...

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