약학회지

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Table. 4.

Table. 4. The timeframe of review process for BLA of Luxturna, Zolgensma, and Hemgenix
Product BLA Submission BLA Approval Review Duration
Luxturna 2017.07 2017.12 5 months*
Zolgensma 2018.10 2019.05 7 months
Hemgenix 2022.03 2022.11 8 months

*Rolling Review

Yakhak Hoeji 2023;67:342-53 https://doi.org/10.17480/psk.2023.67.6.342
© 2023 Yakhak Hoeji