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RHHBY FDA decision dates

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

RHHBY has 6 upcoming FDA decision dates; the nearest is Nov 30, 2026 for Giredestrant (lidERA). 13 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

Nov 30, 2026 in 24 daysGiredestrant (lidERA)Nov 2026 Gazyva (obinutuzumab) - primary membranous nephropathy (MAJESTY)Dec 18, 2026 in 42 daysGiredestrant (+ everolimus)Dec 2026 Gazyva (obinutuzumab) - systemic lupus erythematosus (ALLEGORY)Jan 10, 2027 in 65 daysEnspryng (satralizumab) - MOGAD (METEOROID)Feb 9, 2027 in 95 daysLunsumio VELO (mosunetuzumab) + Polivy - relapsed/refractory LBCL (SUN

Decided

Oct 15, 2026 ✓ ApprovedEnspryng (satralizumab-mwge)Oct 8, 2026 ✓ ApprovedTecentriq (atezolizumab)Sep 25, 2026 ✓ ApprovedGazyva (obinutuzumab)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