Soleno Therapeutics Receives Breakthrough Therapy Designation From FDA For DCCR Extended-Release Tablets in Prader-Willi Syndrome
Soleno Therapeutics Receives Breakthrough Therapy Designation From FDA For DCCR Extended-Release Tablets in Prader-Willi Syndrome
Soleno Therapeutics获得美国食品药品管理局对Prader-Willi综合征的DCCR缓释片剂的突破性疗法认定
First Ever Breakthrough Designation for a Drug Being Developed for PWS
为PWS开发的药物首次获得突破性认定
Designation is Based on Data from the Phase 3 Program for DCCR
指定基于 DCCR 第 3 阶段计划的数据
Planned Submission of a New Drug Application (NDA) for DCCR Remains on Track for Mid-2024
计划于2024年中期提交的DCCR新药申请（NDA）仍在按计划进行
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