The University of Illinois Hospital is the first center in North America to prescribe a new FDA-approved treatment for patients with the most common and aggressive type of brain tumor, glioblastoma multiforme, or GBM.

The hospital is one of the first centers in the U.S. to receive training and certification to treat patients with recurrent GBM with a new therapy called Tumor Treating Fields. This novel, non-invasive therapy is provided using a portable device, the NovoTTF-100A System made by Novocure, which uses alternating electrical fields to disrupt the rapid cell division exhibited by cancer cells.

The U.S. Food and Drug Administration approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.

Federal agencies should develop a new nutrition rating system with symbols to display on the front of food and beverage packaging that graphically convey calorie counts by serving size and a "point" value showing whether the saturated and trans fats, sodium, and added sugars in the products are below threshold levels. This new front-of-package system should apply to all foods and beverages and replace any other symbols currently being used on the front of packaging, added the committee that wrote the report.

Edgemont Pharmaceuticals, LLC, a neuroscience focused company, announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

Fluoxetine, originally marked in the U.S. under the brand name Prozac®, has become a widely-known and used treatment for Major Depressive Disorder, Obsessive Compulsive Disorder in adults and pediatrics, and Bulimia Nervosa and Panic Disorder in adults.

The U.S. Food and Drug Administration approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions, particularly if left untreated or poorly treated.

Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. This marks the 16th approval of REMICADE® in the U.S. and the seventh for the anti-tumor necrosis factor (TNF)-alpha in the treatment of inflammatory bowel disease (IBD) spanning adult and pediatric Crohn's disease and adult and pediatric UC.