May 24, 2917 – The American Food & Drug Administration (FDA) just approved a major extension of the clinical indications for Pembrolizumab (Keytruda). For the first time,  a cancer treatment has been approved for any solid tumor, irrespective of the tumor’s …

First cancer treatment for any solid tumor with MSI-H or dMMR approved Read more »

  April 30, 2017 – The American Food and Drug Administration (FDA) just approved Midostaurin (Rydapt) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who carry particular genetic mutations in the FLT3 (CD135) gene, in combination …

LeukoStrat CDx FLT3 Mutation Assay: New entry in the field of companion tests Read more »

January 19, 2017 – This announcement by the American Food & Drug Administration (FDA) from December 20, 2016, must sound like heaven in the ears of educated patients, technical geeks, and particularly diabetes patients alike. Just see for yourself (announcement largely unedited): …

Sensors and smart devices: Fingerstick testing obsolete for diabetes patients? Read more »

September 22, 2016 – The pharmacologically active compound known as sildenafil is largely used to treat erectile dysfunction (on the market for this indication under the trade name Viagra) and pulmonary arterial hypertension (on the market for this indication under the trade name Revatio) in …

Granpidam: A generic to Sildenafil (Revatio) Read more »

September 19, 2016 – This post presents below a virtually unedited announcement by the American Food & Drug Administration (FDA) concerning Duchenne Muscular Dystrophy (DMD) therapy  option which gives much hope for at least some of the affected patients. However, be …

Eteplirsen (Exondys 51) for Duchenne Muscular Dystrophy (DMD) approved Read more »

 September 17, 2016 – Breast cancer is the most common cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2012. In Europe, there were an estimated 464,000 new cases of breast cancer in 2012 and an estimated 131,000 …

Palbociclib (Ibrance): New treatment for advanced or metastatic breast cancer in the EU Read more »

March 14, 2015 – The American Food and Drug Administration (FDA) just approved Crizotinib (Xalkori) to treat the patient subpopulation with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Crizotinib (Xalkori) is the first …

The use of Crizotinib (Xalkori) has been expanded to treat advanced NSCLC in the patient group who carries a ROS-1 gene alteration Read more »

March 04, 2016 –  On February 25, 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ixekizumab (Taltz), intended for the treatment of plaque psoriasis. Ixekizumab (Taltz) will be available …

Ixekizumab (Taltz) for plaque psoriasis: Positive opinion by the European CHMP Read more »

February 26, 2016 – Two new treatments for oncologic indications have been approved by the American Food and Drug Administration (FDA). Thus, the FDA approved Obinutuzumab (Gazyva) for use in combination with bendamustine followed by Obinutuzumab (Gazyva) monotherapy for the treatment of patients with follicular …

News for Obinutuzumab (Gazyva) and Everolimus (Afinitor) Read more »

 February 19, 2016 – Epilepsy is a brain disorder that causes people to have recurring seizures. A seizure is an episode, usually of relatively short duration, of abnormal brain activity. Seizures can cause a variety of symptoms, including uncontrolled movements or spasms, …

Epilepsy: Brivaracetam (Briviact) approved for the treatment of partial onset seizures Read more »