BAYRY FDA decision dates

Page updated October 23, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

BAYRY has no FDA decision date ahead on the pdufa.bio calendar. 5 past decisions are on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.

BAYRY catalyst hub · full calendar

Decided

Sep 16, 2026 ✓ ApprovedKERENDIA (finerenone), T1D-CKD Sep 9, 2026 ✓ ApprovedHYRNUO (sevabertinib)Jun 15, 2026 ✓ ApprovedAMBELVIST (gadoquatrane)Nov 20, 2025 ✓ ApprovedHYRNUO Oct 24, 2025 ✓ ApprovedLynkuet

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.

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