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

Bitget2026/10/01 05:02

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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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Roche Holding AG published the original content used to generate this news brief via Business Wire (Ref. ID: 202610010100BIZWIRE_USPR_____20260930_BW122135) on October 01, 2026, and is solely responsible for the information contained therein.

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

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