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Antimicrobial Drug Approvals Should Include Pathogen-Specific Indications

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA should be granted authority to approve antimicrobial drugs based on the pathogens they target rather than infection types.

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Cubist Pharmaceuticals laid out the regulatory plan for its novel broad-spectrum cephalosporin/tazobactam combination antibiotic CXA-201 during an R&D day Sept. 20, disclosing plans to go ahead with development of the drug in hospital-acquired and ventilator-associated pneumonia

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