Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...
French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...
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 ...
Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...
Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen Inc ...
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen Inc NASDAQ: AMGN/AstraZeneca’s tezepelumab, and GSK’s mepolizumab are ...
The European Medicines Agency (EMA) approved Sanofi/Regeneron’s Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one. The approval extends the use of Dupixent ...
Regeneron (REGN) and Sanofi (SNY) announced that the European Commission, or EC, has approved Dupixent to treat eosinophilic esophagitis, or EoE, in children as young as one year of age.
The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and ...
Dupixent showed a similar increase of 24%, reaching a level of global sales of $3.82b (most of this volume is recorded by Sanofi (SNY), Regeneron's partner). Moreover, sales growth was recorded ...