Advanced Life Sciences’ Cethromycin Faces Anti-Infectives Panel With Solid Data
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm is first of several near-term NDAs for community acquired pneumonia to come before FDA this year amid changing regulatory standards for anti-infective development.
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Advanced Life Sciences has not given up on developing its investigational drug Restanza (cethromycin) for community acquired pneumonia, despite a June 2 recommendation by the FDA Anti-infective Drugs Advisory Committee that the drug should not be approved for CAP due to lack of efficacy
Advanced Life Sciences Restanza Blocked By New FDA Efficacy Criteria
Advanced Life Sciences has not given up on developing its investigational drug Restanza (cethromycin) for community acquired pneumonia, despite a June 2 recommendation by the FDA Anti-infective Drugs Advisory Committee that the drug should not be approved for CAP due to lack of efficacy
CABP Trial Guidance Snarls Advanced Life Sciences Cethromycin: FDA Panel Votes Against Drug
Company says it remains committed to developing Restanza for community acquired bacterial pneumonia.