The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.
Alkermes PLC headlined new drug and biologic filing news for the week, announcing the submission of a new drug application for ALKS 3831, a combination product that takes aim at the notorious weight gain side effect of the antipsychotic olanzapine.
Samsung Bioepis Co. Ltd. revealed another 351(k) biologics license application, for what could become the third biosimilar to
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.
