MAY 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Herceptin Hylecta (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval for labeling of Herceptin Hylecta; this is a regulatory action record, not a clinical evidence trial.
Reported
Approval date2026-05-18
Product strength600 MG
Route of administrationSubcutaneous injection