Antibacterial Drugs: FDA Panel To Explore Approval Path For Single-Species Agents
US agency’s advisory committee will weigh the pros and cons of five possible development and regulatory pathways, with a specific focus on animal models.
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Antibiotics With Bacteria-Specific, Rather Than Site-Specific, Indication Headed To US FDA
Entasis is seeking a pathogen-specific approval for its antibiotic/beta lactamase inhibitor candidate rather than an indication specific the site of an infection. Achaogen’s earlier failure to do the same may have helped set a path.
Four Early-Stage Antibacterial Drugs To Watch: Highlights From IDWeek
Promising drugs from Tetraphase, ContraFect, Spero and Entasis get a platform at the Infectious Diseases Society of America’s IDWeek.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.