FDA News


FDA Approves Mekinist in Combination with Tafinlar for Advanced Melanoma (January 13, 2014)

The U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) in combination with Tafinlar® (dabrafenib) to treat patients with advanced melanoma. Of the more than one million new diagnoses... Continue Reading

Nexavar Approved for Metastatic Differentiated Thyroid Cancer (December 9, 2013)

The U.S. Food and Drug Administration (FDA) has approved Nexavar® (sorafenib) for the treatment of metastatic differentiated thyroid cancer. Differentiated thyroid cancer is the most common type of thyroid... Continue Reading

Gazyva Approved for CLL (November 22, 2013)

The U.S. Food and Drug Administration (FDA) has approved Gazyva™ (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Chronic... Continue Reading

Perjeta Approved for Neoadjuvant Treatment of Early Stage HER2-Positive Breast Cancer (October 16, 2013)

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Perjeta® (pertuzumab) for the neoadjuvant treatment of early stage breast cancer before surgery. This is the first drug... Continue Reading

Abraxane Approved for Metastatic Pancreatic Cancer (September 20, 2013)

The U.S. Food and Drug Administration (FDA) has approved Abraxane® (paclitaxel protein-bound particles for injectable suspension, albumin-bound) for the treatment of patients with metastatic pancreatic... Continue Reading

Gilotrif Approved for Metastatic EGFR-Positive NSCLC (July 26, 2013)

The U.S. Food and Drug Administration (FDA) has approved Gilotrif™ (afatinib) for the treatment of metastatic non-small cell lung tumors that express specific types of epidermal growth factor receptor... Continue Reading

Xgeva Approved for Treatment of Giant Cell Tumor of the Bone (July 17, 2013)

The U.S. Food and Drug Administration (FDA) has expanded the approved use of Xgeva® (denosumab) to include the treatment of adults and some adolescents with giant cell tumor of the bone (GCTB). Giant... Continue Reading

Lymphoseek Approved for Detecting Lymph Nodes in Breast Cancer and Melanoma (April 10, 2013)

The U.S. Food and Drug Administration (FDA) has approved Lymphoseek® (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients... Continue Reading

Kadcyla Approved for HER2-Positive Metastatic Breast Cancer (March 19, 2013)

The U.S. Food and Drug Administration (FDA) has approved Kadcyla™ (ado-trastuzumab emtansine, formerly known as T-DM1) for the treatment of HER2-positive, metastatic breast cancer that has been previously... Continue Reading

Pomalyst Approved for Advanced Multiple Myeloma (March 13, 2013)

The U.S. Food and Drug Administration (FDA) has approved Pomalyst® (pomalidomide) for the treatment of patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Multiple... Continue Reading

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