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GSK FDA decision dates

Updated ยทnext FDA decision on the calendar

GSK has 2 upcoming FDA decision dates; the nearest is Oct 26, 2026 for Bepirovirsen - (B-Well). 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.

GSK catalyst hub · full calendar

Upcoming

Oct 26, 2026 in 32 daysBepirovirsen - (B-Well)Nov 27, 2026 in 64 daysNeladalkib (NVL-655) - (ALKOVE-1)

Decided

Jun 17, 2026 ✓ ApprovedUtebzi (Tebipenem HBr) - (PIVOMar 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
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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