FDA News


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

Stivarga Approved for Advanced Gastrointestinal Stromal Tumors (March 12, 2013)

The U.S. Food and Drug Administration (FDA) expanded the approved use of Stivarga® (regorafenib)to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed... Continue Reading

Iclusig Approved for CML and ALL (January 4, 2013)

The U.S. Food and Drug Administration (FDA) has approved Iclusig™ (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+... Continue Reading

Synribo Approved for CML (November 8, 2012)

The U.S. Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older... Continue Reading

Stivarga Approved for Metastatic Colorectal Cancer (October 3, 2012)

The U.S. Food and Drug Administration (FDA) has approved Stivarga® (regorafenib) for the treatment of patients with metastatic colorectal cancer that has progressed following previous treatment. Colorectal... Continue Reading

FDA Approves Ultrasound Imaging Device for Dense Breast Tissue (September 27, 2012)

The U.S. Food and Drug Administration (FDA) has approved the somo-v Automated Breast Ultrasound System (ABUS) for use in combination with a standard mammography in women with dense breast tissue who have... Continue Reading

Bosulif Approved for CML (September 26, 2012)

The U.S. Food and Drug Administration (FDA) has approved Bosulif® (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. The drug is... Continue Reading

Xtandi Approved for Metastatic Hormone-Refractory Prostate Cancer (September 13, 2012)

The U.S. Food and Drug Administration (FDA) has approved Xtandi® (enzalutamide) for the treatment of patients with metastatic, hormone-refractory prostate cancer who have previously received docetaxel. The... Continue Reading

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