FDA sets Dec. 18, 2026 PDUFA date for Genentech giredestrant-everolimus NDA in advanced breast cancer

By Public Technologies
  • FDA set PDUFA goal dates for Genentech’s giredestrant in breast cancer: Nov. 30, 2026 for early-stage, Dec. 18, 2026 for advanced.
  • Advanced-disease NDA covers giredestrant with everolimus for ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer.


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