Takeda announces FDA acceptance of BLA for subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease

Takeda

13 September 2023 - Applications for investigational subcutaneous administrations for both Crohn’s disease and ulcerative colitis are now under review by the FDA.

Takeda today announced that the US FDA has accepted for review its biologics license application for the investigational subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active Crohn’s disease after induction therapy with Entyvio intravenous.

Read Takeda press release 

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier