Catalyst Wire Dossier Catalyst Wire Dossier
EMA approval · 2026-04-28

EMA Authorised: Darzalex (daratumumab) — Janssen-Cilag International N.V.

View source ↗

Summary

Authorised status for Darzalex (daratumumab) in the European Union for multiple myeloma with accelerated assessment and orphan designation.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • DARZALEX (daratumumab)

Snippet

Status: Authorised. Therapeutic area: Multiple Myeloma. MAH: Janssen-Cilag International N.V.. Decision date: 26/03/2026. Orphan medicine. Accelerated assessment