The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
Also Read: Regeneron’s Dupixent COPD Sales To Reach $20B By 2026 ... Further boosting the pipeline, mid-stage drugs like ...
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 ...
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 ...
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 ...
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 ...
and Sanofi today announced that the European Commission (EC) has approved Dupixent® (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as 1 year of age. Specifically ...