Neuroblastoma

• EMA approval · 2025-11-26
  EMA Authorised: Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (Dinutuximab beta) — Recordati Netherlands B.V.

  The EMA authorised Qarziba (dinutuximab beta) for neuroblastoma, with orphan medicine status, under Recordati Netherlands B.V. as the market…

• FDA approval · 2025-10-10
  FDA Approved: UNITUXIN — Supplemental Application (United Therapeutics Corporation)

  The FDA approved a supplemental application for UNITUXIN (dinutuximab) from United Therapeutics Corporation.

• EMA approval · 2025-06-18
  EMA Authorised: Phelinun (melphalan hydrochloride) — ADIENNE S.r.l. S.U.

  The EMA authorised Phelinun (melphalan hydrochloride) for multiple cancers including multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphom…

• FDA approval · 2024-12-19
  FDA Approved: CYCLOPHOSPHAMIDE — Original Application (BluePoint Laboratories)

  FDA approved BluePoint Laboratories' original ANDA for cyclophosphamide, establishing a generic version of the chemotherapy agent.

• FDA approval · 2021-01-14
  FDA Approved: VINCRISTINE SULFATE — Supplemental Application (Hospira, Inc.)

  The FDA approved a supplemental application filed by Hospira for vincristine sulfate, a generic vincristine product.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2020-11-25
  FDA Approved: DANYELZA — Original Application (Y-mAbs Therapeutics, Inc.)

  FDA approved DANYELZA (naxitamab) from Y-mAbs Therapeutics for pediatric patients with relapsed or refractory high-risk neuroblastoma confin…

• FDA approval · 2020-09-29
  FDA Approved: UNITUXIN — Supplemental Application (United Therapeutics Corporation)

  FDA granted approval of a supplemental application for Unituxin (dinutuximab) submitted by United Therapeutics Corporation.

• FDA approval · 2017-03-01
  FDA Approved: UNITUXIN — Supplemental Application (United Therapeutics Corporation)

  FDA approved a supplemental application for UNITUXIN (dinutuximab) submitted by United Therapeutics Corporation.

• FDA approval · 2015-03-10
  FDA Approved: UNITUXIN — Original Application (United Therapeutics Corporation)

  FDA approved Unituxin (dinutuximab) from United Therapeutics via an original application for treating pediatric patients with high-risk neur…

• FDA approval · 2013-03-20
  FDA Approved: ADREVIEW — Supplemental Application (Medi-Physics Inc.)

  FDA approved a supplemental application for ADREVIEW (Iobenguane I-123) from Medi-Physics Inc. to update its labeling/indications as a radio…

• CLINICAL_TRIALS approval · 2009-11-09
  Clinical Trial Update: Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma

  Expanded access protocol for [123I]mIBG received marketing approval for use in patients with known or suspected neuroblastoma.

• FDA approval · 2008-09-19
  FDA Approved: ADREVIEW — Original Application (Medi-Physics Inc.)

  FDA approved the original application for ADREVIEW (IOBENGUANE I-123) from Medi-Physics Inc., a radiopharmaceutical imaging agent for locati…