Roche says FDA sets Dec. 18, 2026 PDUFA date for giredestrant in advanced breast cancer

By Public Technologies
  • FDA set PDUFA goal date of Dec. 18, 2026 for Roche’s giredestrant-everolimus NDA in advanced ER-positive breast cancer.
  • Agency also set a Nov. 30, 2026 PDUFA date for giredestrant in early-stage ER-positive breast cancer under Priority Review.


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