the glocalized network in theragenomic and personalized medicine and the genetics of individual patients safety of drugs
May 22, 2014 – The U.S. Food and Drug Administration approved on May 20, 2014, Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease. Entyvio is approved to …
May 13, 2014 – The Pradaxa story continues. See the latest MedWatch Drug Safety Communication, posted on 05/13/2014. ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding …
April 23, 2014 – The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes). MCD causes an abnormal overgrowth of immune …
FDA approves Siltuximab [Sylvant] for rare Castleman’s disease Read more »
April 22, 2014 – The U.S. Food and Drug Administration has just approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. …
FDA approves Ramucirumab [Cyramza] for stomach cancer Read more »
April 18, 2014 – Have you ever heard of Mucopolysaccharidosis Type IVA (Morquio A syndrome)? Most probably not. And I would also think that only very few people are familiar with the “Rare Pediatric Disease Priority Review Voucher Program” by …
April 16, 2014 – The U.S. Food and Drug Administration (FDA) yesterday approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Type 2 diabetes affects approximately 24 million people …
FDA approves Albiglutide [Tanzeum] to treat type 2 diabetes Read more »
April 13, 2014 – The American Food and Drug Administration (FDA) has issued a new Boxed Warning for Valproic Acid [Stavzor] and its association with drug induced liver disease (hepatotoxicity, hepatic failure) which may be fatal in some patients. We …
Valproic Acid [Stavzor]: Newly issued boxed warning for life-threatening liver disease Read more »