The U.S. Food and Drug Administration expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection). The Gore TAG Thoracic Endoprosthesis is the first endovascular graft approved by the FDA to treat a variety of thoracic [ Read More ]
Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. Pneumococcal pneumonia, caused when the bacterium Streptococcus pneumonia e infects the lungs, is the most common disease caused by this [ Read More ]
The U.S. Food and Drug Administration approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found. The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The [ Read More ]
Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the [ Read More ]
The U.S. Food and Drug Administration approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy. Patients with thalassemia have excess iron in the body from the frequent blood transfusions (transfusional iron [ Read More ]
The U.S. Food and Drug Administration and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products. This year’s IIWA, which ran between Sept. 20 and Sept. 27 is called OPERATION PANGEA IV, focused on websites [ Read More ]