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Rabies Monoclonal Antibody Development Plan Gets US FDA Panel Backing

Executive Summary

A second-line indication for rabies post-exposure prophylaxis is the best a monoclonal antibody can initially expect, but postmarketing studies could get the product upgraded to first-line status, the Antimicrobial Drugs Advisory Committee suggests as it endorses the US FDA's proposed development plan in two separate 16-0 votes.

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