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Tuesday, March 17, 2026

FDA extends Lanhteus LNTH-2501 NDA review 3 months, sets new PDUFA target date of June 29

 

Lantheus says FDA extends LNTH-2501 NDA review by three months, sets new PDUFA target date of June 29 2026

  • Extension is to allow the FDA to evaluate additional manufacturing information.
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