These are known as contraindications. The contraindications of Dupixent include: Having had an allergic reaction to Dupixent or any of its ingredients If you’ve had an allergic reaction to ...

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

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

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

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

EMA approves Dupixent to treat eosinophilic esophagitis in children as young as one year: Paris Thursday, November 7, 2024, 14:00 Hrs [IST] The European Medicines Agency has appro ...

Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in CSU, which causes sudden and debilitating hives and recurring itch. The companies said an ...

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

The safety results in the EoE KIDS trial were generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE. The most common adverse reactions for Dupixent ...

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 ...

Safety data across the LIBERTY-CUPID programme were consistent with Dupixent’s established safety profile, with common adverse events including injection site reactions and Covid-19 infections.

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 ...