Ascendis Pharma Announces FDA Accepts Co's Supplemental Biologics License Application For TransCon HGH For The Treatment Of Adults With Growth Hormone Deficiency

Ascendis Pharma宣佈，FDA接受公司對TransCon HGH的補充生物製品許可證申請，旨在治療成年人的生長激素缺乏症。

Benzinga · 2024/12/13 05:02

Ascendis Pharma A/S (NASDAQ:ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) in adult growth hormone deficiency (GHD) for TransCon hGH (lonapegsomatropin-tcgd; marketed as SKYTROFA for pediatric GHD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025.

Ascendis Pharma A/S (納斯達克:ASND) 今日宣佈，美國食品藥品監督管理局 (FDA) 已接受其針對成人生長激素缺乏症 (GHD) 的補充生物製品許可證申請 (sBLA) 進行審查，申請的藥物爲 TransCon hGH (lonapegsomatropin-tcgd；在兒童 GHD 中以 SKYTROFA 銷售)。FDA 設定了處方藥用戶收費法案 (PDUFA) 的目標日期爲 2025 年 7 月 27 日。

譯文內容由第三人軟體翻譯。

以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。

Ascendis Pharma Announces FDA Accepts Co's Supplemental Biologics License Application For TransCon HGH For The Treatment Of Adults With Growth Hormone Deficiency

Ascendis Pharma Announces FDA Accepts Co's Supplemental Biologics License Application For TransCon HGH For The Treatment Of Adults With Growth Hormone Deficiency

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