RHHBY FDA calendar & decision history Roche/Genentech · 2 upcoming · 10 past FDA decisions
Upcoming FDA catalysts RHHBY · Nov 30, 2026 Giredestrant (lidERA) — Adjuvant early breast cancer (ER+/HER2-) RHHBY · Dec 18, 2026 Giredestrant (+ everolimus) — ER+/HER2-, ESR1-mutated metastatic breast cancer FDA decision history (10) Feb 20, 2026✓ Approved CALQUENCE plus venetoclax Dec 22, 2025✓ Approved FDA decision Nov 25, 2025✓ Approved FDA decision Oct 20, 2025✓ Approved FDA decision Oct 2, 2025✓ Approved FDA decision Jul 18, 2025✕ CRL FDA decision May 22, 2025✓ Approved FDA decision Mar 3, 2025✓ Approved FDA decision Feb 12, 2025✓ Approved FDA decision Feb 4, 2025✓ Approved FDA decision See the full 2026 PDUFA calendar → This page aggregates RHHBY's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.
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