FDA Alerts

FDA Proposes Tanning Bed Ban for Underage Kids
Today, the U.S. Food and Drug Administration announced important proposed steps ‎to protect public health by preventing the use of sunlamp products (also commonly known as indoor tanning beds) by minors and reducing the risk of using these devices for adults.
Melanoma Rx Approved as Part of Combo
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 of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).
New Skin Cancer Rx Gets Green Light
On July 24, 2015, the U. S. Food and Drug Administration approved sonidegib (Odomzo Capsules, Novartis Pharmaceuticals Corporation) for the treatment of patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
New Rx for Melanoma Approved
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 longer responding to other drugs.
FDA to Require Warnings on Sunlamp Products
Today, the U.S. Food and Drug Administration issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices.
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer
The US 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.
FDA Issues Proposal to Increase Consumer Awareness of Tanning Bed Risks
Today, the US Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
FDA Approves Lymphoseek to Help Locate Lymph Nodes
The US Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.
FDA Sheds Light on Sunscreens
T he Food and Drug Administration (FDA) is taking steps to help protect consumers from skin damage caused by excessive sun exposure.