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Insmed’s Amikacin Faces US FDA Questions On Surrogate Endpoint, Target Population

Executive Summary

Amikacin liposome inhalation suspension seeking accelerated approval to treat nontubercuolous mycobacterial lung disease caused by Mycobacterium avium complex in adults but has only studied patients with refractory disease; agency also wants its advisory committee to opine on confirmatory trial design.

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