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Melanoma - Metastatic News (Page 3)
Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease
PRINCETON, N.J.--(BUSINESS WIRE)-- December 20, 2017 Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection...
FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma
PRINCETON, N.J.--(BUSINESS WIRE) July 24, 2017 --Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy...
Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status
PRINCETON, N.J., January 23, 2016 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in...
FDA Approves Expanded Indication for Keytruda (pembrolizumab) for the Treatment of Patients with Advanced Melanoma
KENILWORTH, N.J.--(BUSINESS WIRE) December 18, 2015 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has...
FDA Approves Cotellic (cobimetinib) for the Combination Treatment of Advanced Melanoma
November 10, 2015 – The U.S. Food and Drug Administration today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts...
FDA Approves Yervoy to Reduce the Risk of Melanoma Returning after Surgery
October 28, 2015 – Today the U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to...
FDA Approves Imlygic (talimogene laherparepvec) for the Treatment of Melanoma
October 27, 2015 – The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in...
BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma
PRINCETON, N.J., October 1, 2015 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in...
FDA Approves Opdivo (nivolumab) for Advanced Melanoma
December 22, 2014 – The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or...
FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma
September 4, 2014 – The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no...
GSK Gains Accelerated FDA Approval for Combination Use of Mekinist (trametinib) and Tafinlar (dabrafenib)
January 9, 2014 – GlaxoSmithKline plc [LSE/NYSE: GSK ] announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (...
FDA Approves Tafinlar (dabrafenib) for Advanced Melanoma
May 29, 2013 – GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Tafinlar (dabrafenib). Tafinlar is indicated as a single-agent oral treatment for...
FDA Approves Mekinist (trametinib) for Advanced Melanoma
May 29, 2013 – GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist (trametinib) as a single-agent oral treatment for unresectable or metastatic...
FDA Approves Lymphoseek to Help Locate Lymph Nodes in Patients with Certain Cancers
March 13, 2013 – The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph...
FDA Approves Zelboraf and Companion Diagnostic Test for Late-Stage Skin Cancer
Second melanoma drug approved this year that improves overall survival August 17, 2011 - The U.S. Food and Drug Administration today approved Zelboraf (vemurafenib), a drug to treat patients with...