Melanoma
📧 Sign up to get email alerts when something new happens for Melanoma.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2022-09-16FDA Approved: ISOSULFAN BLUE — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved Isosulfan Blue from Novadoz Pharmaceuticals LLC under an Original Application/ANDA, establishing a generic option for uses such…
-
FDA approval · 2022-08-03FDA Approved: TEMOZOLOMIDE — Supplemental Application (Accord Healthcare Inc.)
FDA approves a supplemental application for Temozolomide from Accord Healthcare Inc., a generic cancer drug.
-
FDA approval · 2022-07-28FDA Approved: COTELLIC — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for COTELLIC (cobimetinib) submitted by Genentech, Inc.
-
FDA approval · 2022-03-18FDA Approved: OPDUALAG — Original Application (E.R. Squibb & Sons, L.L.C.)
FDA approved Opdualag (nivolumab and relatlimab-rmbw) based on the original application for unresectable or metastatic melanoma.
-
FDA approval · 2022-02-11FDA Approved: BRAFTOVI — Supplemental Application (Array BioPharma Inc.)
The FDA approved a supplemental application for BRAFTOVI (encorafenib) submitted by Array BioPharma Inc. The specific nature of the suppleme…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2021-05-19FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)
FDA approved a supplemental application for the Kit for the Preparation of Lymphoseek (Technetium-99m Tilmanocept) to prepare Lymphoseek for…
-
FDA approval · 2021-05-07FDA Approved: MEKINIST — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Mekinist (trametinib) from Novartis Pharmaceuticals Corporation.
-
FDA approval · 2020-08-13FDA Approved: TEMOZOLOMIDE — Supplemental Application (Accord Healthcare Inc.)
FDA approves Accord Healthcare Inc.'s supplemental application for temozolomide, supporting a generic version of the drug. The action corres…
-
FDA approval · 2020-06-23FDA Approved: MEKINIST — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for MEKINIST (trametinib) filed by Novartis Pharmaceuticals Corporation.
-
FDA approval · 2020-05-18FDA Approved: ZELBORAF — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Zelboraf (vemurafenib) submitted by Genentech, Inc.
-
FDA approval · 2020-04-08FDA Approved: BRAFTOVI — Supplemental Application (Array BioPharma Inc.)
The FDA approved a supplemental application for BRAFTOVI (encorafenib) filed by Array BioPharma Inc., resulting in an updated indication/lab…
-
FDA approval · 2019-10-06FDA Approved: MEKINIST — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for MEKINIST (trametinib) from Novartis Pharmaceuticals Corporation.
-
FDA approval · 2019-07-12FDA Approved: ISOSULFAN BLUE — Original Application (Somerset Therapeutics, LLC)
FDA approved an original ANDA for Isosulfan Blue from Somerset Therapeutics, LLC, a surgical dye used for sentinel lymph node mapping in bre…
-
FDA approval · 2019-05-24FDA Approved: BRAFTOVI — Supplemental Application (Array BioPharma Inc.)
The FDA approved a supplemental application for BRAFTOVI (encorafenib) submitted by Array BioPharma Inc.
-
FDA approval · 2018-06-27FDA Approved: MEKTOVI — Original Application (Array BioPharma Inc.)
FDA approved MEKTOVI (binimetinib) via an original NDA for unresectable or metastatic NRAS-mutant melanoma, marking the initial approval of …
-
FDA approval · 2018-04-20FDA Approved: TAFINLAR — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for TAFINLAR (dabrafenib) submitted by Novartis Pharmaceuticals Corporation.
-
FDA approval · 2017-11-06FDA Approved: ZELBORAF — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Zelboraf (vemurafenib) submitted by Genentech, Inc., approving a change associated with the supp…
-
FDA approval · 2017-09-13FDA Approved: ZELBORAF — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Zelboraf (vemurafenib) submitted by Genentech, Inc. The action updates the product labeling …
-
FDA approval · 2017-06-22FDA Approved: MEKINIST — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for MEKINIST (trametinib) submitted by Novartis Pharmaceuticals Corporation.
-
FDA approval · 2017-04-17FDA Approved: ZELBORAF — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Zelboraf (vemurafenib) submitted by Genentech, Inc. The action updates the drug’s labeling based…
-
FDA approval · 2017-02-27FDA Approved: TEMOZOLOMIDE — Original Application (Accord Healthcare Inc.)
FDA approved an original application for temozolomide by Accord Healthcare Inc., authorizing a generic version of the cancer drug temozolomi…
-
FDA approval · 2016-11-30FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)
The FDA approved a supplemental application for a kit to prepare Lymphoseek (technetium-99m tilmanocept) for injection, enabling on-site pre…
-
FDA approval · 2016-08-31FDA Approved: ZELBORAF — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Zelboraf (vemurafenib) submitted by Genentech, indicating an approved change to the product labe…
-
FDA approval · 2016-05-31FDA Approved: COTELLIC — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for COTELLIC (cobimetinib) submitted by Genentech, Inc.
-
FDA approval · 2016-02-02FDA Approved: ISOSULFAN BLUE — Original Application (Eugia US LLC)
FDA approved the original application for Isosulfan Blue by Eugia US LLC, authorizing its use as a lymphatic mapping dye for sentinel lymph …