NUVB PDUFA Date: IBTROZI Page updated September 23, 2026 · next FDA decision on the calendar · Data as of Oct 11, 2026 9:31 PM ET FDA decision Approved September 16, 2026 · Nuvation Bio Inc. · ROS1-positive non-small cell lung cancer
Key facts FDA decision Approved September 16, 2026
FDA goal date 2027-01-04
Drug / candidate IBTROZI (taletrectinib)
Indication ROS1-positive non-small cell lung cancer
Company Nuvation Bio Inc.
Market-cap tier Mid
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See the full 2026 PDUFA calendar → FAQ What did the FDA decide on NUVB's IBTROZI? The FDA decided NUVB's (Nuvation Bio Inc.) application for IBTROZI (taletrectinib) on September 16, 2026: Approved. The FDA goal date for this application was 2027-01-04. Verify against the linked primary source.
What is NUVB's drug IBTROZI? IBTROZI (taletrectinib) is Nuvation Bio Inc.'s drug, approved by the FDA on September 16, 2026 for ROS1-positive non-small cell lung cancer.
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