Nuvalent says FDA accepts neladalkib NDA, grants Priority Review with Nov. 27 PDUFA date

Nuvalent

Nuvalent

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  • Nuvalent’s FDA filing for neladalkib in TKI pre-treated advanced ALK-positive NSCLC was accepted with Priority Review.
  • The agency set a PDUFA target action date of Nov. 27, 2026.


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