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 ...

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

市场消息：再生元和赛诺菲向FDA提交新申请，寻求批准Dupixent用于治疗慢性自发性荨麻疹。

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 ...

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric ...

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.

Researchers at New York University have devised a mathematical approach to predict the structures of crystals—a critical step in developing many medicines and electronic devices—in a matter of ...