Japan’s health ministry approved a slew of new medicines on September 25 including multiple “first of its kind” products, among them being GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine Arexvy as well as Eisai’s Alzheimer’s therapy Leqembi (lecanemab).Arexvy became the first…
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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