Melanoma
📧 Sign up to get email alerts when something new happens for Melanoma.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2015-11-10FDA Approved: COTELLIC — Original Application (Genentech, Inc.)
The FDA approved COTELLIC (cobimetinib) from Genentech in an original application, marking its initial regulatory authorization.
-
FDA approval · 2015-08-03FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)
FDA supplemental approval for the KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) by Cardinal Health 414, LLC, enablin…
-
EMA approval · 2015-04-24New treatment for advanced melanoma
EMA announces a new treatment for advanced melanoma, indicating a regulatory approval or positive assessment for a new therapy in this indic…
-
FDA approval · 2014-11-05FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for doxorubicin hydrochloride (Fresenius Kabi USA, LLC) under anANDA to support its generic product.
-
FDA approval · 2014-10-14FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)
The FDA approved a supplemental application to authorize Cardinal Health 414, LLC to prepare the Lymphoseek radiopharmaceutical kit (technet…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2014-09-23FDA Approved: ZELBORAF — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Zelboraf (vemurafenib) submitted by Genentech, Inc.
-
FDA approval · 2014-06-13FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)
FDA approved a supplemental application for a kit used to prepare Lymphoseek (tilmanocept) with technetium-99m, submitted by Cardinal Health…
-
EMA approval · 2014-04-25European Medicines Agency recommends approval of Mekinist for the treatment of melanoma
EMA recommends approval of Mekinist for the treatment of melanoma, signaling potential regulatory authorization for this indication.
-
FDA approval · 2014-03-19FDA Approved: ZELBORAF — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Zelboraf (vemurafenib) from Genentech, marking an approval of a supplemental submission.
-
FDA approval · 2014-02-06FDA Approved: ZELBORAF — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Zelboraf (vemurafenib) submitted by Genentech.
-
FDA approval · 2013-12-04FDA Approved: KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for a kit used to prepare Technetium-99m sulfur colloid for nuclear medicine imaging.
-
FDA approval · 2013-07-03FDA Approved: ZELBORAF — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Zelboraf (vemurafenib) from Genentech, Inc.
-
EMA approval · 2013-06-28European Medicines Agency recommends approval of Tafinlar for the treatment of metastatic melanoma
EMA recommends approval of Tafinlar (dabrafenib) for treating metastatic melanoma, indicating regulatory support for its use in this indicat…
-
FDA approval · 2013-05-29FDA Approved: MEKINIST — Original Application (Novartis Pharmaceuticals Corporation)
The FDA approved MEKINIST (trametinib) from the original application for the treatment of unresectable or metastatic melanoma with BRAF V600…
-
FDA approval · 2013-03-13FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Original Application (Cardinal Health 414, LLC)
FDA approved the kit for the preparation of Lymphoseek (technetium-99m tilmanocept), enabling production of the radiopharmaceutical used for…
-
FDA approval · 2013-01-08FDA 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 · 2011-08-17FDA Approved: ZELBORAF — Original Application (Genentech, Inc.)
The FDA approval document records the original approval for Zelboraf (vemurafenib) by Genentech, marking its first approval for treating pat…
-
EMA approval · 2009-12-31EMA Refused: Genasense (oblimersen) — Genta Development Ltd. c/o Ross Craig
The EMA refused approval for Genasense (oblimersen) for melanoma, indicating a negative outcome in the regulatory decision.
-
FDA approval ·FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
FDA grants accelerated approval for Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy for treatment-…