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 ...

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

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, ...

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 ...

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

Dupixent approved in the EU as the first and only medicine for young children with eosinophilic esophagitisApproval based on phase 3 data showing ...

Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 ...

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 ...

The most common adverse reactions for Dupixent overall are injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. In addition, the adverse ...

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 most common adverse reactions for Dupixent overall are injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. In addition, the adverse ...