August 01, 2015 – On July 24, 2015, the American Food and Drug Administration (FDA) approved Alirocumab (Praluent) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. …

Alirocumab (Praluent): A new treatment option for patient suffering from high cholesterol Read more »

July 31, 2015 – This week, just in time for World Hepatitis Day on July 28, the American Food and Drug Administration (FDA) approved Daclatasvir (Daklinza)  for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. In addition, the …

A very exciting week for patients with hepatitis C viral (HCV) infections of the genotypes 3 and 4 Read more »

July 13, 2015 – This post persents a press announcement by the U.S. Food and Drug Administration (FDA).  The text has slightly been edited by the autor of this blog. Thus, FDA today approved Gefinitib (Iressa) for the first-line treatment …

Theragenomic Medicine: Gefinitib (Iressa) targeted therapy for first-line treatment of patients with a type of metastatic lung cancer approved Read more »

Percutaneous Coronary Intervention (PCI) Causes

June 26, 2015 –  The following is good news for patients who will need percutaneous coronary intervention (PCI), however, bleeding problems are not completely resolved. But see for yourself. The U.S. Food and Drug Administration just approved Cangrelor (Kengreal), an intravenous antiplatelet …

Cangrelor (Kengreal) a newly approved antiplatelet drug used during PCI heart procedure Read more »

June 06, 2015 –  On May 22, 2015, the European Medicines Agency (EMA) has recommended granting a marketing authorisation for Unituxin (Dinutuximab) for the treatment of high-risk neuroblastoma, a type of cancer that most often occurs in young children. Unituxin (Dinutuximab) is to be used in children …

Treatment with Unituxin (Dinutuximab) for high-risk neuroblastoma in children recommended by EMA Read more »

March 22, 2015 – This post addresses a topic which often gets lost in the current hype on targeted and precision (theragenomic) medicine. The issue is that targeted therapies are not only very precise and highly effective (in most patients) …

Theragenomic Medicine: Targeted Therapies and Associated Toxicity Read more »

February 8, 2015 – The American Food and Drug Administration (FDA) has granted accelerated approval to Palbociclib (Ibrance) to treat advanced (metastatic) breast cancer.  The FDA granted Ibrance breakthrough therapy designation because the sponsor demonstrated through preliminary clinical evidence that the …

Theragenomic Medicine: Palbociclib (Ibrance) approved for postmenopausal women with advanced (metastatic) breast cancer Read more »

January 17, 2015 – The following post is an excerpt from a recent (December 30, 2014) publication by Janet Woodcock, M.D., on FDA Voice. She talks about the FDA’s upcoming Sentinel System, which will have a huge impact on how in future …

Full Scale “Active Surveillance”: The Sentinel System Read more »

December 20, 2014 – Right in time for Christmas, the American Food & Drug Admininistration (FDA) on December 19 approved three significant new drugs, namely Ceftolozane/Tazobactam (Zerbaxa), Ombitasvir/Paritaprevir/Ritonavir co-packaged with Dasabuvir (Viekira Pak) and Olaparib (Lynparza), each of which represents …

Right in time for Christmas, FDA approved Ceftolozane/Tazobactam (Zerbaxa), Ombitasvir/Paritaprevir/Ritonavir co-packaged with Dasabuvir (Viekira Pak), and Olaparib (Lynparza) Read more »