Merck’s C. Diff Drug Zinplava Clears FDA With Heart Failure Warning
Executive Summary
Following panel recommendation, label includes warning of use of bezlotoxumab in patients with history of congestive heart failure; postmarketing commitments include studies on microbial retention and endotoxin recovery.
You may also be interested in...
Antibiotic Pipeline Profile: Narrowing The Spectrum Of Drug Activity
Development is most advanced in C. difficile infection, but US FDA's exploration of pathways to expedite single pathogen treatments could spur earlier-stage QIDP projects targeting Staphylococcus and Pseudomonas species.
Seres Argues Different Diagnostic Needed In Recurrent C. Difficile Trials
As it talks study design with FDA, Seres says new analysis of Phase II trial of microbiome candidate SER-109 suggests that a C. difficile cytotoxin test would be more accurate and that a higher dose may be more effective.
Keeping Track: Merck's Winning Week; Novel Agents Submitted By GSK, Melinta, Portola
The latest drug development news and highlights from our FDA Performance Tracker.