The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
After a long road that included a three-month delay as the agency pushed for additional data, the US FDA has approved Sanofi and Regeneron's Dupixent (dupilumab) for COPD - as has China's National ...
Also Read: Regeneron’s Dupixent COPD Sales To Reach $20B By 2026 ... Further boosting the pipeline, mid-stage drugs like ...
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...
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 ...
SNY Sanofi Dupixent® ... (COPD) Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent ...
Also Read: Regeneron’s Dupixent COPD Sales To Reach $20B By 2026 ... Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen ...