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FDA shuns Rocket's immune disorder gene therapy over manufacturing shortcomings

By Yahoo! Finance   |   Jul 1, 2024 at 11:27 AM EST
FDA shuns Rocket's immune disorder gene therapy over manufacturing shortcomings

The FDA has rejected Rocket Pharmaceutical's gene therapy Kresladi for severe leukocyte adhesion deficiency-I due to manufacturing concerns. This delay impacts approval timeline and voucher eligibility. Rocket aims to provide requested information promptly to move forward.

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