食药局拒绝新西兰药剂局短时间的肠道综合症治疗(glepagluttide), FDA rejects Zealand Pharma's short bowel syndrome treatment, glepaglutide, citing safety and efficacy concerns.

林业发展局向新西兰制药公司发出了一份全面答复函,表示对短肠综合症的治疗即glepaglutide的申请不符合证明其安全和有效性所需的标准。 The FDA has issued a Complete Response Letter to Zealand Pharma, stating that the application for glepaglutide, a treatment for short bowel syndrome, did not meet the required standards for proving its safety and efficacy. 美国食品和药物管理局建议进行额外的临床试验. The FDA recommends an additional clinical trial. 西兰制药计划继续与FDA进行讨论,并打算在2025年提交欧洲申请. Zealand Pharma plans to continue discussions with the FDA and intends to proceed with a European submission in 2025.