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

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore ...

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 ...

Dr. Meijing Wu is described by friends and colleagues as a distinguished biostatistician and “a kind and generous friend who ...

Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma Recommendation based on IMROZ phase 3 study demonstrating Sarclisa in combination with ...

Despite rebukes by two federal circuit courts, an HHS sub-agency continues to overstep its authority when administering a ...

Key players in the Hematologic Malignancies Therapeutics Market include Pfizer, Inc., F. Hoffmann-La Roche Ltd, Sanofi-Aventis, Bristol-Myers Squibb Company, AbbVie, Inc., Novartis AG, GlaxoSmithKline ...

Corbus Pharmaceuticals still shows promise, with CRB-701 and CRB-601 advancing in clinical trials. Read why CRBP stock is ...