GSK PDUFA Date: Neladalkib Updated September 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Nov 27, 2026 · GSK plc · TKI-pretreated ALK-positive NSCLC
Key facts FDA PDUFA target date 2026-11-27
Drug / candidate Neladalkib (NVL-655)
Indication TKI-pretreated ALK-positive NSCLC
Company GSK plc
Market-cap tier Large
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All November 2026 PDUFA dates → FAQ When is the GSK PDUFA date? The FDA PDUFA target date for GSK (GSK plc) is 2026-11-27 for Neladalkib (NVL-655). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is GSK's drug Neladalkib? Neladalkib (NVL-655) is GSK plc's candidate under FDA review for TKI-pretreated ALK-positive NSCLC.
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