一次情報の記録
決定級FDA 承認
Humacyte Symvess BLA、血管外傷向けにFDA承認取得
同文書によると、FDAは2024年12月に四肢血管外傷を対象としたSymvess BLAを承認し、米国市場での発売は2025年に開始された。これにより、本製品は治験段階の製品から、米国で即時商業利用可能な承認済み生物製剤へと移行した。
主要事実
出典の抜粋
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