11月7日 - 节奏制药公司宣布,FDA已延长针对获得性下丘脑肥胖患者的IMCIVREE®(setmelanotide)的审核期限。FDA设定了更新后的PDUFA目标日期为2026年3月20日。FDA在10月要求对获得性下丘脑肥胖的3期试验的有效性数据进行额外的敏感性分析。此次重大修订并未包含任何与setmelanotide的安全性或生产相关的信息。
11月7日 - 节奏制药公司宣布,FDA已延长针对获得性下丘脑肥胖患者的IMCIVREE®(setmelanotide)的审核期限。FDA设定了更新后的PDUFA目标日期为2026年3月20日。FDA在10月要求对获得性下丘脑肥胖的3期试验的有效性数据进行额外的敏感性分析。此次重大修订并未包含任何与setmelanotide的安全性或生产相关的信息。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.