IDM Pharma (NASDAQ:IDMI) announced today that the company has submitted an electronic New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Junovan(TM) (mifamurtide for injection), requesting approval for its use in the treatment of newly diagnosed resectable high grade osteosarcoma patients following surgical resection in combination with multiple agent chemotherapy.
Schering-Plough Corporation (NYSE: SGP) reported that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL(R) (posaconazole) Oral Suspension for the treatment of oropharyngeal candidiasis (OPC), including infections refractory to itraconazole and/or fluconazole. OPC is a fungal infection of the mouth and throat caused by the yeast Candida. NOXAFIL is a novel triazole antifungal agent discovered and developed by Schering-Plough Research Institute.
Many people with constipation are confused about the cause of their condition and its appropriate treatment with laxatives. Results of a new large-scale global survey, announced today, show that many people wrongly fear that laxatives are addictive and that their use for long periods of time actually causes constipation.1,2
Believe it or not, the holiday season is just around the corner. Before you know it, the streets will be bustling with shoppers, malls will be donned with holiday decor, and the sounds of the season will be echoing through your ears — bringing with them the anticipation of seeing family and friends once again for a season filled with good times, good memories, and great holiday foods.
Merck & Co., Inc. announced that the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that adults 60 years of age and older be vaccinated with ZOSTAVAX? [Zoster Vaccine Live (Oka/Merck)] to help prevent shingles (herpes zoster), a frequently painful disease marked by a blistering rash.
The gastrointestinal medicine Zelnorm? (tegaserod maleate) has demonstrated potential benefits in helping patients with the multiple symptoms of a common digestive disorder called dysmotility-type dyspepsia[1], according to new Phase III data presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting.
Novartis announced the US regulatory approval of Tyzeka(TM) (telbivudine) as a new once-a-day oral treatment for patients with chronic hepatitis B, a disease estimated to affect about 1.25 million people in the US but more than 350 million globally and considered the tenth leading cause of death.
On October 13, 2006, the U.S. Food and Drug Administration (FDA) alerted the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors. These test strips are used by people with diabetes to measure their blood glucose. Today’s announcement provides two additional lot numbers that are included in the distribution of counterfeit products, along with descriptions of how to identify them.
The Food and Drug Administration (FDA) announced the approval of Omnaris (ciclesonide) nasal spray, a new drug for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis, commonly known as hay fever, in adults and children 12 years of age and older.
An observational prospective study was conducted by AS Olafsdottir,a GV Skuladottir,b I Thorsdottir,a A Hauksson,c L Steingrimsdottird to investigate the interaction of smoking status and dietary intake during pregnancy and its relationship to maternal weight gain and birth size parameters in four hundred and eight healthy pregnant Icelandic women.