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Saturday, June 27, 2026

Lantheus CRL for LNTH-2501 NDA over unresolved third-party manufacturing issues

 Lantheus receives FDA Complete Response Letter for LNTH-2501 NDA over unresolved third-party manufacturing facility issues

  • FDA cites unresolved issues at a third-party manufacturing facility supporting LNTH-2501 (Ga 68 edotreotide).
  • Complete Response Letter notes no safety or efficacy concerns but delays potential approval timeline for LNTH-2501.
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