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Monday, March 16, 2026

FDA accepts Cogent NDA for bezuclastinib, sets December 30, 2026 PDUFA

 

FDA accepts Cogent Biosciences NDA for bezuclastinib in NonAdvanced Systemic Mastocytosis, sets December 30, 2026 PDUFA date

  • FDA does not plan an advisory committee meeting for the bezuclastinib NDA in NonAdvanced Systemic Mastocytosis.
  • FDA identified no review issues at this time for the bezuclastinib NonAdvanced Systemic Mastocytosis application.
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