The US Food and Drug Administration has approved Herceptin (trastuzumab) in combination with chemotherapy for HER2-positive metastatic stomach and gastroesophageal junction cancers, the drug’s manufacturer, Roche, announced.
The US Food and Drug Administration has asked manufacturers of gonadotropin-releasing hormone agonists, which are used to treat men with prostate cancer, to carry warnings on their labels about the potential risk of heart disease and diabetes.
New safety information has been added to the label for the HIV therapy, Invirase (saquinavir), describing potentially life-threatening side effects on the heart when used with Novir (ritonavir), the US Food and Drug Administration announced.
The US Food and Drug Administration has approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with atrial fibrillation. The product has been developed by Boehringer Ingelheim GmbH.
Eli Lilly and Co, Amylin Pharmaceuticals Inc and Alkermes Inc have received a ‘complete response letter’ from the US Food and Drug Administration for Bydureon which is intended to improve glycemic control for adults with Type 2 diabetes.
Genmab A/S said that, based on discussions with regulators, it has sufficient data to file a marketing authorisation application in Europe for zalutumumab for the second-line treatment of patients with head and neck cancer.
The US Food and Drug Administration has approved the use of Botox (onabotulinumtoxinA) to prevent headaches in adults with chronic migraine. This is the newest indication for a product that was first approved for eye muscle disorders.
The European Medicines Agency has adopted new conflict-of-interest rules for the experts that advise its scientific committees. In future, declarations from the agency’s experts will be published on the EMA website.
The US Food and Drug Administration has issued a warning about the possible risk of atypical thigh bone fracture in patients who take bisphosphonates which are used to prevent and treat osteoporosis. Manufactures are being asked to alter their labels.
Merck Serono has announced plans to appeal against the European Medicines Agency’s decision not to recommend approval of its candidate multiple sclerosis drug, Movectro (cladribine). The negative opinion was issue on 23 September 2010.