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 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 ...

Also Read: Regeneron’s Dupixent COPD Sales To Reach $20B By 2026 ... Further boosting the pipeline, mid-stage drugs like ...

Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 ...

Regeneron released a strong financial report for Q3 and was the 15th of 16 in the last four years. Read why I upgrade REGN ...

With increasing chronic diseases, demand for personalized medicines, and adoption of AI, the biotech market is booming.

"Over one million patients around the globe are currently being treated with Dupixent, with more to come following the approvals for COPD in the ... The Company and Sanofi announced that a ...

“Over one million patients around the globe are currently being treated with Dupixent, with more to come following the approvals for COPD in the U.S., Europe and ... The Company and Sanofi announced ...

Sanofi (NASDAQ:SNY ... execute and meet the need for more treatment options. The expansion of Dupixent and COPD will give hundreds of thousands of additional patients who are living with this ...