Washington, DC - The U.S. Food and Drug Administration Friday expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.

Washington, DC - The U.S. Food and Drug Administration announced Thursday that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.

Washington, DC - The United States is deeply disappointed by Wednesday’s court decision in Burma to allow prosecution of Reuters reporters Wa Lone and Kyaw Soe Oo under the Official Secrets Act.

Sacramento, California - A portion of San Diego County has been placed under quarantine for the Mexican fruit fly following the detection of seven flies within the City of Encinitas.  The United States Department of Agriculture (USDA), the San Diego County Agricultural Commissioner, and the California Department of Food and Agriculture (CDFA) are working collaboratively on this project.

Pacific Ocean - Wasp departed Norfolk August 30 to replace USS Bonhomme Richard (LHD 6) in Sasebo, Japan as the forward-deployed amphibious assault ship in region.

Washington, DC - Multi-level marketers sell a wide variety of products and services and they structure their companies in different ways. But there’s a lodestar that all industry members can use to navigate through issues that may arise – and here it is:  Core consumer protection principles apply to all MLMs. FTC staff has just released business guidance to help MLMs apply those core principles to their business practices.