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獲得美國食品藥品管理局對Prader-Willi綜合徵的DCCR緩釋片劑的突破性療法認定
First Ever Breakthrough Designation for a Drug Being Developed for PWS
爲PWS開發的藥物首次獲得突破性認定
Designation is Based on Data from the Phase 3 Program for DCCR
指定基於 DCCR 第 3 階段計劃的數據
Planned Submission of a New Drug Application (NDA) for DCCR Remains on Track for Mid-2024
計劃於2024年中期提交的DCCR新藥申請（NDA）仍在按計劃進行
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