This makes the new indication for Dupixent very important for Sanofi as it searches for a blockbuster to transform its fortunes. The FDA is set to make a decision on Dupixent’s new indication on ...

After a long road that included a three-month delay as the agency pushed for additional data, the US FDA has approved Sanofi and Regeneron's Dupixent (dupilumab) for COPD - as has China's National ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

Regeneron announced Friday that the company won Food and Drug Administration approval for Dupixent in chronic obstructive ...

Dupixent significantly reduced itch and hive ... to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron ...

FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Regeneron ...

Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in CSU, which causes sudden and debilitating hives and recurring itch. The companies said an ...

Sanofi (SNY) has released an update. Sanofi’s Dupixent has received EU approval as the first treatment for children aged one to 11 with eosinophilic esophagitis, expanding its market potential ...

On Friday, Sanofi SA (NASDAQ:SNY) reported a third-quarter business operating income of 4.61 billion euros ($4.99 billion), up 14.4% year-over-year and 19.9% in constant currency. The company ...