原始出處紀錄
決策級FDA 核准
Humacyte Symvess BLA 獲 FDA 核准用於四肢血管創傷
文件指出 FDA 已於 2024 年 12 月核准 Symvess BLA 用於四肢血管創傷，且美國市場已於 2025 年開始推出。這使該資產從研究中產品轉為已核准的生物製劑，並可在美國立即商業化使用。
關鍵事實
來源摘錄
EX-99.1 2 tm269106d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Universally Implantable Regenerative Human Tissue 2 Disclaimer These slides and the accompanying oral presentation contain forward-looking statements. All statements, other than statements of historical fact, included in these slides and the accompanying oral presentation are forward-looking statements reflecting management’s current beliefs and expectations. In some cases, you can identify forward-looking statements by terminology such as “will,” “anticipate,” “expect,” “believe,” “intend” and “should” or the negative of these terms or other comparable terminology. Forward-looking statements in these slides and the accompanying oral presentation include, but are not limited to, statements about our plans and ability to commercia