Glioma

• EMA approval · 2026-08-18
  EMA Authorised: Temodal (temozolomide) — Merck Sharp & Dohme B.V.

  Temodal (temozolomide) has been authorised in the EU for glioma.

• EMA approval · 2026-03-30
  EMA Authorised: Finlee (dabrafenib mesilate) — Novartis Europharm Limited

  The European Medicines Agency has authorised Finlee (dabrafenib mesilate). The medicine is indicated for glioma and has orphan medicine desi…

• EMA approval · 2025-11-06
  EMA Authorised: Temodal (temozolomide) — Merck Sharp & Dohme B.V.

  The EMA authorised Temodal (temozolomide) for glioma, with Merck Sharp & Dohme B.V. as the marketing authorisation holder; decision date 06/…

• EMA approval · 2025-11-03
  EMA Authorised: Spexotras (trametinib dimethyl sulfoxide) — Novartis Europharm Limited

  The European Medicines Agency authorised Spexotras (trametinib dimethyl sulfoxide) for glioma. The product carries orphan medicine designati…

• EMA approval · 2025-07-10
  EMA Authorised: Temozolomide Sun (temozolomide) — Sun Pharmaceutical Industries Europe B.V.

  The European Medicines Agency has authorised Sun Pharmaceutical's temozolomide product for the treatment of glioma.

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• EMA approval · 2025-06-02
  EMA Authorised: Temozolomide Accord (temozolomide) — Accord Healthcare S.L.U.

  EMA authorised Temozolomide Accord (temozolomide) from Accord Healthcare S.L.U. for glioma.

• CLINICAL_TRIALS approval · 2024-11-05
  Clinical Trial Update: Vorasidenib Expanded Access Program

  Vorasidenib’s expanded access program update notes that vorasidenib has been approved for marketing for glioma recurrence.

• EMA approval · 2024-10-30
  EMA Authorised: Gliolan (5-aminolevulinic acid hydrochloride) — Photonamic GmbH & Co. KG

  The EMA authorised Gliolan (5-aminolevulinic acid hydrochloride) for use in glioma, with Photonamic GmbH & Co. KG as the marketing authoriza…

• FDA approval · 2024-08-06
  FDA Approved: VORANIGO — Original Application (Servier Pharmaceuticals LLC)

  FDA granted original approval for Voranigo (vorasidenib) by Servier Pharmaceuticals LLC for adult patients with IDH1-mutant glioma.

• EMA approval · 2024-05-16
  EMA Authorised: Temozolomide Teva (temozolomide) — Teva B.V.

  EU marketing authorization granted for Temozolomide Teva (temozolomide) for glioma.

• EMA approval · 2022-03-28
  EMA Authorised: Temomedac (temozolomide) — medac Gesellschaft für klinische Spezialpräparate mbH

  Temomedac (temozolomide) has been authorised in Europe for glioma by medac, with decision date 25/03/2022.