Blog Archives

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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FDA: Sweeping new federal ruling bars e-cigarette sales to teens younger than 18

May 5, 2016 – Today, the American Food and Drug Administration (FDA) finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others, which includes the barring of sales of these products to teens under 18 years old.

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Pimavanserin (Nuplazid) approved to treat hallucinations and delusions associated with Parkinson’s disease

April 29, 2016 – The American Food and Drug Administration (FDA) has approved Pimavanserin (Nuplazid), the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. Pimavanserin (Nuplazid) acts as an inverse agonist on the serotonin receptor subtype 5-HT2A,

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Dietary supplements containing kratom have been seized in the United States

January 6, 2016 – The American Food and Drug Administration (FDA) just announced that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom, which itself contains as component, among others, the compound mitragynine.

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

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 specifically for treating their advanced lung cancer.

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Theragenomic medicine: FDA approves Osimertinib (Tagrisso) to treat patients with non-small cell lung cancer (NSCLC) who carry the EGFR mutation T790M

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 epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.

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Sonidegib (Odomzo): A second Hedgehog pathway inhibitor approved as new treatment for most common form of advanced skin cancer

August 02, 2015 – The American Food and Drug Administration (FDA) very recently approved Sonidegib (Odomzo) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.

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A very exciting week for patients with hepatitis C viral (HCV) infections of the genotypes 3 and 4

July 31, 2015 – This week, just in time for World Hepatitis Day on July 28, the American Food and Drug Administration (FDA) approved Daclatasvir (Daklinza)  for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. In addition,

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Codeine cough-and-cold medicines in children: A never ending story – FDA evaluating potential risk of serious side effects

July 6. 2015 – The American Food and Drug Administration (FDA) is once more investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing. Children,

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New Treatment Modality: Nivolumab (Opdivo) has been approved for the treatment of patients with previously treated metastatic squamous non-small cell lung cancer (NSCLC)

June 17, 2015 – Bristol Myers Squipp recently announced that the U.S. Food and Drug Administration (FDA) has approved Nivolumab (Opdivo) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. 

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  • Development and analytical validation of a next-generation sequencing based microsatellite instabili October 18, 2019
    The referenced article describes an assay that has a clinically relevant five-day turnaround time and can be conducted on as little as 20 ng genomic DNA with a batch size of up to forty samples in a single run.
  • Lifestyle is a threat to gut bacteria: Ötzi proves it October 18, 2019
    The intestinal microbiome is a delicate ecosystem made up of billions and billions of microorganisms, bacteria in particular, that support our immune system, protect us from viruses and pathogens, and help us absorb nutrients and produce energy. The industrialization process in Western countries had a huge impact on its content. This was confirmed by a […]
  • Singapore completes whole genome sequencing analysis of multi-ethnic Asian populations October 18, 2019
    A new genetic databank has been established containing the completed whole-genome sequencing (WGS) data of close to 5,000 Singaporeans. Worldwide, WGS is increasingly used in research and healthcare to identify genetic variations using cutting-edge technologies that allow large numbers of individuals to be sequenced rapidly—This new study is the world's largest WGS analysis of Asian […]
  • Researchers quantify limitations of health reports from direct-to-consumer genetic tests October 17, 2019
    Health reports from direct-to-consumer (DTC) genetic tests that use a limited variant screening approach often yield clinical false-negative results, which pose the risk of informing health care decisions based on incomplete information, according to findings presented at the American Society of Human Genetics (ASHG) 2019 Annual Meeting in Houston, Texas.
  • Researchers develop mouse model of human gene involved in Alzheimer's disease October 17, 2019
    In research that helps scientists better understand and explore treatments for diseases like Alzheimer's, scientists have developed a line of mice in which the mouse version of the Alzheimer's-associated MAPT gene has been fully replaced by the human version of the gene. In this new animal model, known as a full gene-replacement model, the MAPT […]
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