Bayer HealthCare Pharmaceuticals AG is banking that a "totality of the evidence" argument proves persuasive with a US FDA advisory committee, which will weigh the efficacy and safety of inhalable ciprofloxacin for bronchiectasis despite two Phase III studies that failed most of their primary endpoints.
FDA's Antimicrobial Drugs Advisory Committee will meet Nov. 16 to discuss Bayer's new drug application (NDA) for a dry powder...
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