FDA Advisors Give Entasis Antibiotic Unanimous Thumbs Up, But Call For Strong Postmarket Surveillance
High unmet need and a potentially more favorable safety profile than current options got sulbactam-durlobactam a favorable advisory panel.
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Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.