BRIEF-Lantheus Receives Complete Response Letter From FDA For Lnth-2501 (Ga 68 Edotreotide)

Lantheus Holdings Inc

Lantheus Holdings Inc

LNTH

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June 26 (Reuters) - Lantheus Holdings Inc LNTH.O:

  • LANTHEUS RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR LNTH-2501 (GA 68 EDOTREOTIDE)

  • LANTHEUS HOLDINGS - FDA CANNOT APPROVE LNTH-2501 NDA BY JUNE 29, 2026 DUE TO MANUFACTURING CONDITIONS

  • LANTHEUS HOLDINGS - LNTH-2501 NDA APPROVAL REQUIRES RESOLUTION OF FACILITY INSPECTION CONDITIONS

  • LANTHEUS HOLDINGS - CRL DOES NOT IDENTIFY DATA, SAFETY, OR EFFICACY CONCERNS FOR LNTH-2501

Source text: ID:nGNX19FQfC

Further company coverage: LNTH.O


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