原始来源记录
决策级FDA 批准
Humacyte Symvess BLA 获 FDA 批准用于四肢血管创伤
该文件显示，FDA 于 2024 年 12 月批准了 Symvess 的 BLA，用于四肢血管创伤，美国市场于 2025 年启动上市。这将该资产从研究性产品转变为已获批的生物制品，在美国立即可商业化供应。
关键事实
来源摘录
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