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RHHBY FDA decision dates

Updated ยทnext FDA decision on the calendar

RHHBY has 4 upcoming FDA decision dates; the nearest is Oct 9, 2026 for Tecentriq (atezolizumab) adjuvant - (stage III colon). 10 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.

RHHBY catalyst hub · full calendar

Upcoming

Oct 9, 2026 in 15 daysTecentriq (atezolizumab) adjuvant - (stage III colon)Oct 15, 2026 in 21 daysEnspryng (satralizumab) - (thyroid eye disease)Nov 30, 2026 in 67 daysGiredestrant (lidERA)Dec 18, 2026 in 85 daysGiredestrant (+ everolimus)

Decided

Feb 20, 2026 ✓ ApprovedCALQUENCE plus venetoclaxDec 22, 2025 ✓ ApprovedLunsumio VELONov 25, 2025 ✓ Approvedprice-onlyOct 20, 2025 ✓ Approvedprice-onlyOct 2, 2025 ✓ ApprovedZepzelcaJul 18, 2025 CRLprice-onlyMay 22, 2025 ✓ ApprovedSusvimoMar 3, 2025 ✓ ApprovedTNKaseFeb 12, 2025 ✓ ApprovedEVRYSDIFeb 4, 2025 ✓ ApprovedSusvimo
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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