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Neural tube defects with Dolutegravir-based HIV medications

May 22, 2018 –The American Food and Drug Administration (FDA) just released a Safety Alert concerning serious neural tube defects that might arise in babies born to women who took HIV medications that contained the active ingredient Dolutegravir. Neural tube defects are birth defects that can occur early in pregnancy when the spinal cord,

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eHealth: Viz.AI Contact App to alert for stroke in patients

February 15, 2018 – The American Food and Drug Administration (FDA) just permitted marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients.

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Lutetium 177 dotatate (Lutathera): A treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

January 29, 2018 – Gastroenteropancreatic neuroendocrine tumors (GEP-NET)s are a rare group of cancers with limited treatment options that affects primarily the pancreas or gastrointestinal tract of patients.  

The American Food &

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Vemurafenib (Zelboraf) for BRAF V600E positive Erdheim-Chester Disease (ECD)

Dezember 21, 2017 – Erdheim–Chester disease ((ECD), also known as Erdheim–Chester syndrome or polyostotic sclerosing histiocytosis) is a form of a bone marrow borne blood cancer. It is a rare disease characterized by the abnormal multiplication of a specific type of white blood cells called histiocytes,

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Are there life-threatening health problems with Limbrel?

November 22, 2017 – Limbrel (Flavocoxid) is a medical food. A medical food is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements,

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Febuxostat (Uloric): Gout medication with increased risk for heart-related death?

November 19, 2017 – Gout is a terrible condition for those affected. Gout is a form of inflammatory arthritis characterized by recurrent attacks of a red, tender, hot, and swollen joint. Pain typically comes on rapidly in less than twelve hours. The joint at the base of the big toe is affected in about half of cases. 

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Is there a risk of melanoma with erectile dysfunction drugs?

November 01, 2017 – According to the watch list of the American Food & Drug Administration (FDA) for drugs with possible safety issues from January to March 2016,

the FDA was looking at the possible link between various drugs in the phosphodiesterase-5 (PDE-5) inhibitors class and melanoma as a serious adverse effect.

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Axicabtagene Ciloleucel (Yescarta) gene therapy for diffuse large B-cell lymphoma

October 19, 2017 – The American  Food & Drug Administration (FDA) just approved Axicabtagene Ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment.

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The first gene therapy FDA approved in the US

September 3, 2017 – For a very first time, the American Food & Drug Administration (FDA) has approved a gene therapy for the United States (US) in that it approved CAR T-cell therapy to treat certain children and young adults with B-cell acute lymphoblastic leukemia (B-cell ALL).

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Pembrolizumab (Keytruda): Clinical trials on hold

September 2, 2017 – The American Food & Drug Administration (FDA) has announced that two clinical trials with Pembrolizumab (Keytruda) in patients with multiple myeloma have been put on hold. The FDA informs the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Pembrolizumab (Keytruda) in combination with dexamethasone and an immunomodulatory agent (Lenalidomide (Revlimid) or Pomalidomide (Pomalyst)) for the treatment of patients with multiple myeloma.

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