FDA Decision Due on Roche's Giredestrant for Early Breast Cancer
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Roche
SCHEDULED78% CONFIDENCERoche's[1] release says "The FDA is expected to make a decision on the approval by 30 November 2026", the PDUFA goal date set under Priority Review.
The FDA is due to decide by 30 November 2026 whether to approve Roche's giredestrant, an oral SERD that cut the risk of recurrence or death by 30% versus standard hormone therapy in early ER-positive breast cancer.
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