Record mula sa primary source
Decision-gradePag-apruba ng FDA
Humacyte Symvess BLA inaprubahan ng FDA para sa extremity vascular trauma
Nakasaad sa dokumento na inaprubahan ng FDA ang Symvess BLA noong Disyembre 2024 para sa extremity vascular trauma, at nagsimula ang paglulunsad sa merkado ng U.S. noong 2025. Binabago nito ang asset mula sa isang investigational product tungo sa isang aprubadong biologic na may agarang komersyal na pagkakaroon sa Estados Unidos.
Mahahalagang fact
- Na-file
- Mar 19, 2026, 12:25 PM
- Kaganapan
- Pag-apruba ng FDA
- Direksyon
- Positibo
- Kumpanya
HUMAHumacyte- Asset
- ATEV
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Antas ng pagputol ng galamay
- 4.5%
- Pangunahing pagiging bukas (patency)
- 87.1%
- Pangalawahing pagiging bukas (patency)
- 91.5%
- Antas ng impeksyon sa daluyan
- 0.9%
Sipi mula sa source
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
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HUMAHumacyteHumacyte muling inihanay ang mga karapatan sa labas ng U.S. para sa Symvess kasama ang Fresenius