((自动化翻译由路透提供,请见免责声明 )) (第2段增加股份,第3和第4段增加疾病详情,第5-7段增加背景资料)
路透9月19日 - 美国食品和药物管理局拒绝批准万达制药公司 治疗胃麻痹症状的药物。
该公司股价在盘前交易中下跌约14%,至4.26美元。
万达正在寻求卫生监管机构批准该公司的药物tradipitant用于治疗胃瘫,胃瘫是一种以胃排空延迟为特征的疾病。
胃瘫是一种以胃排空延迟为特征的疾病,患者会出现严重恶心、呕吐和难以完成正常进餐等症状。
万达公司从礼来 公司获得了替替匹坦的授权,目前也在研究它对晕车症的治疗作用。
卫生监管机构对替替匹坦实施了部分临床搁置,禁止进行超过12周的试验。
该公司计划在今年晚些时候提交一份单独的药物申请,以防止晕车呕吐。
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