EMA
withdrawal
· 2023-06-14
EMA Refused: Omblastys (iodine (131I) omburtamab) — Y-Mabs Therapeutics A/S
Summary
EMA refused the Omblastys application (iodine-131 omburtamab) for neuroblastoma, leading to no approval at this time.
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Diseases / indications
Drugs mentioned
Snippet
Status: Refused. Therapeutic area: Neuroblastoma. MAH: Y-Mabs Therapeutics A/S. Decision date: 15/12/2022. Orphan medicine