Highlights of the latest drug development news from our US FDA Performance Tracker.
Applications for US FDA approval for two high-profile, first-in-class candidates, Novartis AG’s inclisiran and Pfizer Inc. and Eli Lilly & Co.’s tanezumab, were revealed last week, as the fast pace of submissions in the waning days of 2019 continues into the new year.
Genentech Inc. returned to the FDA’s real-time oncology review (RTOR) pilot program, which in 2019 produced speedy approvals for...
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.
