A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…
BUSINESS
FDA Nixes Takeda’s Subcutaneous Entyvio Formulation
The US FDA has issued a complete response letter for a subcutaneous (SC) formulation of Takeda Pharmaceutical’s inflammatory bowel disease treatment Entyvio (vedolizumab), rejecting its approval as a maintenance therapy for moderate to severe active ulcerative colitis (UC). The Japanese…
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