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Complete Response for regulatory review of Ultomiris in the treatment of adult patients with neuromyelitis optica spectrum disorder – AstraZeneca

Written by | 15 Sep 2023

The FDA has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for the treatment of adult… read more.

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