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waskyra
etuvetidigene autotemcel
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
waskyra
Proper name
etuvetidigene autotemcel
Licence type
351(a)
BLA number
125846
Applicant
Fondazione Telethon Ets
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1.9-11.4x10^6CD34+ CELLS/ML | Solution | Intravenous | Bag | Rx | December 9, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |