Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...
The BOREAS Phase III trial showed DUPIXENT reduced exacerbations by 30% and improved lung function by 160 mL at 52 weeks.
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 ...
The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and ...
Eli Lilly’s Ebglyss (lebrikizumab-lbkz) showed improvement in skin clearance and itch relief for most patients with ...
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 weeks compared to placebo, which was sustained up to ...