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.
Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...
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 ...
The drug also had a favorable safety profile, indicating its potential as a game-changer for those with type 2 inflammation.
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 activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by ...
2 Top Growth Stocks to Buy on the Dip was originally published by The Motley Fool ...
The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and ...