FDA
label_change
· 2026-04-07
FDA Approved: SKYCLARYS — Supplemental Application (Biogen)
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
Snippet
SUPPL AP for SKYCLARYS (OMAVELOXOLONE)