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FDA label_change · 2026-04-07

FDA Approved: SKYCLARYS — Supplemental Application (Biogen)

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Summary

The FDA approved Biogen's supplemental application for Skyclarys (omaveloxolone). This approval updates the labeling for this Friedreich's ataxia therapy.

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Diseases / indications

Drugs mentioned

  • SKYCLARYS (omaveloxolone)

Snippet

SUPPL AP for SKYCLARYS (OMAVELOXOLONE)