The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
Category Archives: Drug Safety Information Podcasts
FDA clears first blood tracking device that uses Radio Frequency Identification technology
iTrace for Blood Centers, (Version 1.0.924.0), the first application to use Radio Frequency Identification (RFID) technology in blood establishments to assist in enhancing blood safety by preventing the release of unsuitable blood components, was cleared today by the U.S. Food and Drug Administration.
FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee
The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.
FDA allows marketing of first A1c test labeled for diagnosing diabetes
Today the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first HbA1c test that FDA has allowed to be marketed for this use.
FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy
The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients.
FDA seeks preliminary injunction against New York fish manufacturer
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to become adulterated.
FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC).
FDA approves Nymalize–first nimodipine oral solution for use in certain brain hemorrhage patients
On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule.
FDA approves new drug for advanced prostate cancer
The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.
FDA approves Simponi to treat ulcerative colitis
The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.