Business · 29/08/2025Updated: 10/17/2026 · 1 min read

Amylyx Pharmaceuticals Withdraws RELYVRIO NDA Approval

Summary

Amylyx Pharmaceuticals has voluntarily requested the FDA to withdraw approval of its new drug application for RELYVRIO, a treatment for a rare genetic disorder, citing a desire to avoid a potentially contentious hearing process.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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