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GSK FDA decision dates

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

GSK has 1 upcoming FDA decision date; the nearest is Nov 2026 for Neladalkib (NVL-655) - (ALKOVE-1). 12 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.

GSK catalyst hub · full calendar

Upcoming

Nov 2026 Neladalkib (NVL-655) - (ALKOVE-1)

Decided

Oct 20, 2026 ✓ ApprovedHibsago (bepirovirsen)Oct 19, 2026 ✓ ApprovedJemperli (dostarlimab-gxly)Jun 17, 2026 ✓ ApprovedUtebzi (Tebipenem HBr)Mar 19, 2026 ✓ ApprovedLinerixibat - (GLISTEN)Mar 13, 2026 ✓ ApprovedArexvyDec 11, 2025 ✓ ApprovedBlujepaOct 23, 2025 ✓ ApprovedBlenrepJul 17, 2025 ✓ ApprovedShingrixJun 24, 2025 ✓ ApprovedBenlystaMay 22, 2025 ✓ ApprovedNucalaMar 25, 2025 ✓ ApprovedBlujepaFeb 17, 2025 ✓ Approvedprice-only