1차 출처 기록
결정급FDA 승인
Humacyte Symvess BLA, FDA가 사지 혈관 외상 치료용으로 승인
문서에 따르면 FDA는 2024년 12월 사지 혈관 외상 치료용 Symvess BLA를 승인했으며, 미국 시장 출시는 2025년에 시작되었습니다. 이로써 해당 자산은 임상시험용 제품에서 미국 내 즉시 상용화 가능한 승인된 생물의약품으로 전환되었습니다.
핵심 사실
출처 발췌
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