US FDA accepts for review the resubmission of sBLA for Dupixent to treat chronic spontaneous urticaria: Paris Monday, November 18, 2024, 11:00 Hrs [IST] The US Food and Drug Admin ...

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.

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 ...

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 ...

AEs more commonly observed with Dupixent (≥5%) compared to placebo included injection site reactions (12% vs. 4%), accidental overdose (7% vs. 3%) and COVID-19 infection (8% vs. 5%). Dupixent ...

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 ...

Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to ...

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 ...