Malignant Melanoma

• EMA approval · 2026-03-18
  EMA Authorised: Opdivo (nivolumab) — Bristol-Myers Squibb Pharma EEIG

  EMA authorised Opdivo (nivolumab) for multiple cancer indications, including melanoma, Hodgkin lymphoma, renal cell carcinoma, non-small cel…

• FDA approval · 2023-03-16
  FDA Approved: TAFINLAR — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved TAFINLAR (dabrafenib) under an Original Application for patients with unresectable or metastatic melanoma harboring a BRAF V600…

• FDA approval · 2023-03-16
  FDA Approved: MEKINIST — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved MEKINIST (trametinib) in its original application for unresectable or metastatic melanoma with BRAF V600E or V600K mutations (i…

• FDA approval · 2022-10-28
  FDA Approved: COTELLIC — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for COTELLIC (cobimetinib) from Genentech, expanding its labeling. The action relates to the tre…

• FDA approval · 2021-11-03
  FDA Approved: ISOSULFAN BLUE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' original application for Isosulfan Blue, a surgical dye used to identify sentinel lymph nodes during …

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• FDA approval · 2019-05-17
  FDA Approved: PROLEUKIN — Supplemental Application (Iovance Biotherapeutics, Inc)

  FDA approved a supplemental application for PROLEUKIN (aldesleukin) filed by Iovance Biotherapeutics. The approval updates the product label…

• FDA approval · 2018-06-27
  FDA Approved: BRAFTOVI — Original Application (Array BioPharma Inc.)

  FDA approved BRAFTOVI (encorafenib) under the original application (NDA210496) from Array BioPharma Inc., marking the drug's initial approva…

• FDA approval · 2018-01-26
  FDA Approved: COTELLIC — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for COTELLIC (cobimetinib) from Genentech, Inc.

• FDA approval · 2016-04-27
  FDA Approved: TEMOZOLOMIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for temozolomide in a generic form, enabling Rising Pharma Holdings, Inc. to market temozolomide.

• FDA approval · 2015-05-06
  FDA Approved: PROLEUKIN — Supplemental Application (Iovance Biotherapeutics, Inc)

  The FDA approved a supplemental application for PROLEUKIN (aldesleukin) filed by Iovance Biotherapeutics, Inc, indicating an updated regulat…

• FDA approval · 2014-11-25
  FDA Approved: ZELBORAF — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Zelboraf (vemurafenib) submitted by Genentech, Inc., representing an additional regulatory actio…

• FDA approval · 2013-05-29
  FDA Approved: TAFINLAR — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved TAFINLAR (dabrafenib) as an original application for the treatment of unresectable or metastatic malignant melanoma with BRAF V…

• EMA approval · 2011-12-16
  European Medicines Agency recommends approval of first-in-class treatment for metastatic or unresectable melanoma

  EMA recommends approval of a first-in-class treatment for metastatic or unresectable melanoma, indicating a new mechanism is being brought t…

• 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 · 2011-03-25
  FDA Approved: YERVOY — Original Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved YERVOY (ipilimumab) under the original application from E.R. Squibb & Sons for the treatment of malignant melanoma.

• FDA approval · 2009-02-27
  FDA Approved: TEMODAR — Original Application (Merck Sharp & Dohme LLC)

  FDA approved TEMODAR (temozolomide) as an original application for the treatment of malignant melanoma.