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Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.
Following two workforce cuts in 2022, Finch said it will cut its staff by 95%, halting a Phase III study of lead recurrent C. diff candidate CP101 and seeking to maximize shareholder value.
Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.
The US FDA’s use of outside expert advisory committees rebounded from historic lows in 2022 – but just barely. Will Commissioner Califf’s ‘update’ of the process finally mean more committee meetings in 2023?
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