November 08, 2018 –  The American Food and Drug Administration (FDA) has just authorized the first direct-to-consumer test for detecting genetic variants in genes that may govern the metabolism of drugs in individual patients. Thus, FDA permits marketing, with special controls, the …

Living theragenomic medicine: Direct to consumer test for metabolism of drugs FDA approved Read more »

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 …

Neural tube defects with Dolutegravir-based HIV medications Read more »

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 …

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

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, with 40x selectivity over 5-HT2C, and …

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

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 …

Dietary supplements containing kratom have been seized in the United States 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 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 »

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 …

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

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, the …

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

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 …

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