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

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

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 ...

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

Dupixent has been approved for CSU in Japan and the United Arab Emirates (UAE) and is also under regulatory review in the European Union based on earlier trial readouts. Outside of Japan and the UAE, ...

Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.

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

The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.

Looking at options history for Regeneron Pharmaceuticals REGN we detected 8 trades. If we consider the specifics of each ...

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, ...