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Latest From Mallinckrodt plc
Keeping Track: Genmab/AbbVie Epkinly, Krystal’s Vyjuvek Join US FDA’s 2023 Novel Approvals List
Oncology's surprisingly low numbers this year are among the latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Deal Watch: Vertex Calls On CRISPR Yet Again, Now To Collaborate On Type 1 Diabetes
Vertex and CRISPR look beyond beta thalassemia and sickle cell disease. Also, Bicycle gets $50m up front in Novartis deal, Regeneron commits $75m initially under a Treg collaboration with Sonoma, and Jounce gets a better deal from Concentra to wave off Redx merger.
End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes
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.
Will US FDA Advisory Committees Rebound In 2023?
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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