BAYRY FDA calendar & decision history Bayer · 2 upcoming · 3 past FDA decisions
Upcoming FDA catalysts BAYRY · Nov 30, 2026 Sevabertinib (BAY 2927088) — HER2-mutant NSCLC, 1L (sBLA, Priority Review) BAYRY · Dec 31, 2026 KERENDIA (finerenone) — Type 1 diabetes + CKD (FINE-ONE, sNDA) FDA decision history (3) Jun 15, 2026✓ Approved AMBELVIST (gadoquatrane) Nov 20, 2025✓ Approved FDA decision Oct 24, 2025✓ Approved FDA decision See the full 2026 PDUFA calendar → This page aggregates BAYRY'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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