Blog Archives

Fingolimod (Gilenya): Warning about rare cases of progressive multifocal leukoencephalopathy (PML)

August 06, 1015 – The American Food and Drug Administration (FDA) has just issued a warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Fingolimod (Gilenya) for multiple sclerosis (MS).

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

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 drug may offer a substantial improvement over available therapies.

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Theragenomic Medicine: Genotyping Might Cut Muscle-Pain Risk with Statin Drugs

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 that affect the drugs’

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Steps to strengthen cybersecurity of medical devices

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.

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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

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 CYP2D6 Ultrametabolizer Patient Subgroup because oaf their CYP2D6 genetic background.

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US: Approval of Alglucosidase Alfa [Lumizyme] to treat Pompe disease expanded to patients of all ages

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,

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

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 responses to standard treatment for CLL.

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Idelalisib (Zydelig) for three types of blood cancers approved

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).

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Weight Loss Products: Public Notification – Undeclared Drug Ingredients

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 at high risk of individual health damage (i.e., adverse effects,

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

July 17, 2014The 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 by having insufficient amounts of a plasma protein called C1-esterase inhibitor,

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  • Descendants of early Europeans and Africans in US carry Native American genetic legacy September 19, 2019
    Many people in the U.S. do not belong to Native American communities but still carry bits of Native American DNA, inherited from European and African ancestors who had children with indigenous individuals during colonization and settlement. In a new study published 19th September in PLOS Genetics, Andrew Conley of the Georgia Institute of Technology and […]
  • IGF1 gene is essential to adult tendon growth, animal study shows September 19, 2019
    Tendon injuries are among the most common injuries seen in athletes at all levels, from weekend warriors to professional basketball players. For those who rupture their tendons, returning to the same level of physical activity they enjoyed before the injury is rare.
  • Researchers create new protocol to improve gene therapy tool production September 19, 2019
    A method to create a faster and lower cost alternative for a gene therapy tool has been developed by Boston University School of Medicine (BUSM) researchers.
  • Genetic variants with possible positive implications for lifestyle September 19, 2019
    A German and British research team lead by Technical University of Munich (TUM) has examined the interplay between genetics, cardiovascular disease and educational attainment in a major population study. Genetic variants which had been linked to educational attainment in other studies were observed in the subjects. The researchers found that these variants also had implications […]
  • Scientists develop new methodology to genetically modify lab mice and human cells September 19, 2019
    A team led by Cedars-Sinai has designed a rapid method to genetically alter laboratory mice and then used this method to produce personalized animal models of pediatric glioma, an aggressive type of malignant brain cancer in children.
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