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 »

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 »

October 05, 2014 – To strengthen the safety of medical devices, the U.S. Food and Drug Administration has finalised and released recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. The final guidance, titled “Content …

Steps to strengthen cybersecurity of medical devices 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 »

July 28, 2014 – The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor …

The use of Ibrutinib [Imbruvica] expanded to the treatment of chronic lymphocytic leukaemia Read more »

July 23, 2014 – The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned (relapsed). …

Idelalisib (Zydelig) for three types of blood cancers approved Read more »

July 22, 2014 –  Over and over again do we read announcements by the American Food and Drug Administration (FDA)  such as the most recent one below. The producers and vendors of this type of “health” products put patients knowingly …

Weight Loss Products: Public Notification – Undeclared Drug Ingredients Read more »

July 17, 2014 – The U.S. Food and Drug Administration (FDA) recently approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Hereditary angioedema, which is caused …

FDA approves the new product Ruconest (recombinant C1-Esterase inhibitor) to treat the rare genetic disease by the name of hereditary angioedema (HAE) Read more »

July 01, 2014 – As the knowledge of genetics and genomics rapidly expand, a personalized approach to health care is becoming increasingly important. India is fast becoming a promising contender in the global healthcare arena The majority of the global …

India steps closer to Personalized Medicine Read more »