The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
After a sedate 2023 so far, the US FDA changed pace by clearing three novel agents over three days: Pharming Group NV’s Joenja (leniolisib) on 24 March for a rare immunologic deficiency and Cidara Therapeutics, Inc.’s antifungal Rezzayo (rezafungin) and Incyte Corporation’s immuno-oncologic Zynyz (retifanlimab-dlwr) on 22 March 2023.
The approvals bring the Center for Drug Evaluation and Research’s novel approval count to 13 for the year. Five of...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
