December 16, 2015 – This post is somewhat delayed; however, it may still be of  interest for some readers of thasso post and therefore, the information is provided here uncommented, as it was issued by both the FDA and the EMA …

Idarucizumab (Praxbind): Antidote for Dabigatran (Pradaxa) approved by FDA and recommended for approval by EMA Read more »

December 5, 2015 – A safety review by the American Food and Drug Administration (FDA) has resulted in the addition of specific warnings to the drug labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors …

SGLT2 Inhibitors and ketoacidosis: Warnings about too much acid in the blood and serious urinary tract infections included in new drug labels Read more »

December 02, 2015 –  The American Food and Drug Administration (FDA) just granted approval for Elotuzumab (Empliciti) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. Elotuzumab (Empliciti) is a monoclonal …

Elotuzumab (Empliciti), a new immune-stimulating therapy to treat multiple myeloma has been approved Read more »

November 28, 2015 – The American Food and Drug Administration (FDA) just approved Necitumumab (Portrazza) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication …

Necitumumab (Portrazza) approved for the treatment of advanced squamous non-small cell lung cancer (NSCLC) Read more »

November 21, 2015 – During the last few days, the American Food and Drug Administration  (FDA) just extended the armamentarium in the fight against multiple myeloma by two new entries, namely Ixazomib (Ninlaro) and Daratumumab (Darzalex). Both drugs are intended to treat …

FDA extends armamentarium to treat multiple myeloma: Ixazomib (Ninlaro) and Daratumumab (Darzalex) approved Read more »

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 »

November 13, 2015 – The American Food and Drug Administration (FDA) just approved Cobimetinib (Cotellic) to be used in combination with Vemurafenib (Zelboraf) to treat advanced melanoma that has spread to other parts of the body or can’t be removed by …

Cobimetinib (Cotellic) is now approved as part of a combination treatment with Vemurafenib (Zelboraf) for advanced melanoma Read more »

November 06, 2015 – Just about the same time at the End of October 2015, the American Drug and Food Administration (FDA) has approved, and the European Medicines Agency (EMA) has recommended for approval Talimogene Laherparepvec (Imlygic), a first-in-class advanced therapy medicinal product (ATMP) derived from a …

Imlygic, a first-of-its-kind oncolytic immunotherapy for the treatment of melanoma 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 »

Immune Checkpoint Regulation: The role of the PD-1/PDL1 pathway.

October 11, 2015 – In recent months, Nivolumab (Opdivo), a human IgG4 anti-PD-1 monoclonal antibody which targets the PD-1 receptor, had been approved first for the treatment of unresectable  or advanced (metastatic) melanoma and secondly for the treatment of advanced (metastatic) squamous non-small cell …

Nivolumab (Opdivo) demonstrates survival benefit in squamous and non-squamous non-small cell lung cancer (NSCLC) Read more »