November 14, 2015 – The American Food and Drug Administration (FDA) just granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Osimertinib (Tagrisso) was approved for patients whose tumors have a specific …

Theragenomic medicine: FDA approves Osimertinib (Tagrisso) to treat patients with non-small cell lung cancer (NSCLC) who carry the EGFR mutation T790M Read more »

August 15, 2015 – Please find here the abstract of an recent article which is concerned with the genetic basis of smoking and the prospects of smoking cessation therapies in individual smokers.  The author of this blog thought it worthwhile …

Theragenomic Medicine: Where there is a cigarette, there is smoke. How much, that may be in your genes. Read more »

April 4, 2015 – There’s nothing like the real world to shed light on the safety of new drugs and devices. Clinical trials may be the best way to compare treatments, but patients enrolled in trials are carefully selected and …

Could the HCV drug sofosbuvir be cardiotoxic? Is there a role in genetic predisposition? Read more »

December 12, 2014 – The American Food & Drug Administration (FDA) has recently issued a warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can …

Rare But Potentially Fatal Skin Reactions (DRESS Syndrome) with Ziprasidone [Geodon] 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 »

August 1. 2014 – The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk …

US: Approval of Alglucosidase Alfa [Lumizyme] to treat Pompe disease expanded to patients of all ages Read more »

May 01, 2014 – This is a fantastic article on a very difficult to understand topic, with often very sad outcomes.  The source of the article is Medscape and it reveals how combined efforts from different scientific appoaches may lead …

Just Wait A Little Longer: Suicide Biomarkers Getting Closer to the Clinic 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 »

March 28, 2014 – This is a press release by the FDA (announcement relayed without modification): The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. …

FDA approves first long-acting recombinant coagulation Factor IX concentrate for patients with Hemophilia B Read more »