Skip to main content

Entyvio FDA Approval History

FDA Approved: Yes (First approved May 20, 2014)
Brand name: Entyvio
Generic name: vedolizumab
Dosage form: Injection
Company: Takeda Pharmaceutical Company Limited
Treatment for: Crohn's Disease, Active, Ulcerative Colitis

Entyvio (vedolizumab) is an integrin receptor antagonist for the treatment of Crohn's disease and ulcerative colitis.

Development timeline for Entyvio

DateArticle
Apr 18, 2024Approval U.S. FDA Approves Subcutaneous Administration of Takeda’s Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease
Sep 27, 2023Approval U.S. FDA Approves Subcutaneous Administration of Takeda's Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis
May 20, 2014Approval FDA Approves Entyvio (vedolizumab) to treat Ulcerative Colitis and Crohn's Disease
Dec  9, 2013FDA Advisory Committee Recommends Approval of Takeda's Investigational Biologic Vedolizumab
Sep  4, 2013Takeda's New Investigational Drug Vedolizumab is Granted Priority Review Status by U.S. Food and Drug Administration for Ulcerative Colitis
Aug 21, 2013Data Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to Severely Active Ulcerative Colitis and Crohn's Disease
Jun 21, 2013Takeda Submits BLA for Vedolizumab for Moderately to Severely Active Crohn's Disease and Ulcerative Colitis

See also

Entyvio (vedolizumab) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer