The FDA had rejected the companies’ initial application in 2023, requesting additional data after the pharma firms reported ...

April 18 (Reuters) - The U.S. Food and Drug Administration approved the use of Sanofi (SASY.PA), opens new tab and Regeneron's (REGN.O), opens new tab blockbuster drug Dupixent for patients with a ...

The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes ...

TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved ...

Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo In the US, there are more than 300,000 adults and adolescents aged 12 years and older ...

Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and adolescents over 12 years of age in over a decade. The FDA has approved Regeneron’s ...

Sanofi and Regeneron Pharmaceuticals drug Dupixent has won FDA approval for chronic spontaneous urticaria, introducing a new approach to the treatment of this inflammatory skin disorder.

Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo In the US, there are more than 300,000 adults and adolescents aged 12 years and ...

Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch ...

Regeneron Pharmaceuticals and Sanofi won U.S. Food and Drug Administration expanded approval of their blockbuster anti-inflammatory drug Dupixent for the inflammatory skin condition chronic ...