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ONC FDA calendar & decision history

BeOne Medicines Ltd. · 1 upcoming · 2 past FDA decisions

Upcoming FDA catalysts

ONC · Aug 25, 2026Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01) — First-line HER2-positive gastroesophageal adenocarcinoma (GEA)

FDA decision history (2)

May 13, 2026✓ ApprovedBEQALZI (Sonrotoclax)Dec 8, 2025✕ CRLFDA decision
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This page aggregates ONC'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.