July 9, 2016 – This is a huge step into the future of theragenomic and personalized medicine and individualized drug safety. In support of the President’s Precision Medicine Initiative (PMI), the American Food & Drug Administration (FDA) just issued two …

Precision Medicine Initiative: draft guidances issued Read more »

February 07, 2016 – The European Commission has approved once-daily Osimertinib (Tagrissa) for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) that is positive for the epidermal growth-factor receptor (EGFR) T790M mutation. This follows a positive review in …

Osimertinib (Tagrissa) approved for non-smal cell lung cancer (NSCLC) patient subgroup carrying the EGFR T790M mutation Read more »

February 04, 2016 – Genetic variations on a stretch of chromosome may predict responsiveness among patients with bipolar disorder to the mood stabilizing drug lithium (multiple brands), a genome-wide analysis by an international consortium shows. Lithium is a first-line treatment for …

Genetic Variants Predict Lithium Response in Bipolar Disorder Read more »

December 24, 2015 – The American Food and Drug Administration (FDA) just approved Lesinurad  (Zurampic) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a …

Is there help for patients suffering from gout? Lesinurad (Zurampic) approved for the treatment of high blood uric acid levels Read more »

October 28, 2015 – According to a  small prospective and randomized clinical study, just published online in the Annals of Internal Medicine, a regularly taken glass of wine with dinner may improve lipid and glycemic control profiles in patients with type 2 …

Theragenomic medicine and social habits: A regularly taken glass of wine may improve cardiometabolic risks in some patients with type 2 diabetes Read more »

July 2, 2015 – The following post would constitute a perfect example how theragenomic and personalized medicine may help patients who carry genetic predispositions for sometimes rather debilitating and eventually fatal diseases. Thus, the U.S. Food and Drug Administration (FDA) today …

Theragenomic medicine: Orkambi approved by the FDA as a new treatment for cystic fibrosis Read more »

November 20, 2014 –  Recent research has addressed the clinically strikingly wide variation among patients in plasma levels of Atorvastatin (Lipitor) and Rosuvastatin (Crestor), even with consistent dosing. This research proposes that the phenomenon is likely related to gene variants …

Theragenomic Medicine: Genotyping Might Cut Muscle-Pain Risk with Statin Drugs Read more »

September 27, 2014 – A while ago (August 2012),  the American Food and Drug Administration (FDA) was assessing and reporting on the (possibly fatal) risks associated with the use of codeine containing medicines in children who are phenotypically members of the …

FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death 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 »

October 10, 2013 – Very recently, David Kerr, Professor of Cancer Medicine at University of Oxford, in the United Kingdom, and past President of the European Society for Medical Oncology, talked on Medscape (see the video here) about risk-benefit analyses …

Can We Identify Risk for Drug Toxicity? Read more »