Glioblastoma

• 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/…

• FDA approval · 2022-04-13
  FDA Approved: ALYMSYS — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves ALYMSYS as a biosimilar to bevacizumab (bevaczizumab-maly) from Amneal Pharmaceuticals LLC under an original Biologics License …

• FDA approval · 2020-11-20
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Temodar (temozolomide) filed by Merck Sharp & Dohme LLC, resulting in updated labeling to re…

• FDA approval · 2019-11-22
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for TEMODAR (temozolomide) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2019-06-27
  FDA Approved: ZIRABEV — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves ZIRABEV (bevacizumab-bvzr) from Pfizer as a biosimilar to Avastin under an Original Application. The approval covers multiple b…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2018-08-22
  FDA Approved: GLEOLAN — Supplemental Application (Medexus Pharma, Inc.)

  FDA approved a supplemental application for Gleolan (aminolevulinic acid hydrochloride) submitted by Medexus Pharma, Inc. This action consti…

• FDA approval · 2018-06-12
  FDA Approved: GLEOLAN — Supplemental Application (Medexus Pharma, Inc.)

  FDA approved a supplemental application for Gleolan (aminolevulinic acid hydrochloride) submitted by Medexus Pharma, Inc.

• FDA approval · 2017-09-14
  FDA Approved: MVASI — Original Application (Amgen, Inc)

  The FDA approved MVASI (bevacizumab-awwb) from Amgen as a biosimilar to Avastin, marking the original application granting U.S. approval for…

• FDA approval · 2017-06-06
  FDA Approved: GLEOLAN — Original Application (Medexus Pharma, Inc.)

  The FDA approved Gleolan (aminolevulinic acid hydrochloride) from Medexus Pharma under NDA208630 for use in fluorescence-guided visualizatio…

• FDA approval · 2017-02-24
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Temodar (temozolomide) filed by Merck Sharp & Dohme LLC. The action updates Temodar's labeling t…

• FDA approval · 2015-09-18
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for TEMODAR (temozolomide) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2015-06-10
  FDA Approved: TEMOZOLOMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for temozolomide from Sun Pharmaceutical Industries, Inc., under ANDA201742, granting a supplemental…

• FDA approval · 2015-06-01
  FDA Approved: GLIADEL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for GLIADEL (carmustine) filed by Azurity Pharmaceuticals, Inc.

• FDA approval · 2015-04-02
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Temodar (temozolomide) from Merck, resulting in an updated labeling and/or indication for th…

• FDA approval · 2014-11-20
  FDA Approved: GLIADEL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for GLIADEL (carmustine wafer) from Azurity Pharmaceuticals, Inc., to modify/expand its labeling…

• FDA approval · 2014-02-12
  FDA Approved: TEMOZOLOMIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a generic temozolomide product under an original ANDA from Sun Pharmaceutical Industries, Inc. Temozolomide is used to treat ma…

• FDA approval · 2013-08-16
  FDA Approved: GLIADEL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for GLIADEL (carmustine) by Azurity Pharmaceuticals, Inc. The approval updates the product’s labelin…

• FDA approval · 2013-08-15
  FDA Approved: GLEOSTINE — Supplemental Application (NextSource Biotechnology, LLC)

  The FDA approved a supplemental application for Gleostine (lomustine) submitted by NextSource Biotechnology, LLC.

• FDA approval · 2013-01-08
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for TEMODAR (temozolomide) submitted by Merck Sharp & Dohme LLC, resulting in an approved change…

• FDA approval · 2011-06-03
  FDA Approved: TEMODAR — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Temodar (temozolomide) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2006-12-26
  FDA Approved: GLIADEL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for GLIADEL (carmustine) by Azurity Pharmaceuticals, Inc.