February 26, 2020 – Fragile X syndrome (FXS) is a genetic disorder characterized by mild-to-moderate intellectual disability.The average IQ in males is under 55, while about two thirds of females are intellectually disabled. Physical features may include a long and narrow …

The first genetic test to aid in the diagnosis of Fragile X Syndrome Read more »

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May 30, 2019 – The American Food and Drug Administration (FDA) recently approved Alpelisib (Piqray) to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor …

The PI3K inhibitor Alpelisib (Piqray) for progressing breast cancer in women (and men) Read more »

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March 31, 2019 – The American Food and Drug Administration (FDA) has just approved  drugs for two rather problematic neurological conditions, namely multiple sclerosis (i.e., Cladribine (Mavenclad)) and non-radiographic axial spondyloarthritis (i.e., Certolizumab pegol (Cimzia)), offering patients with these conditions …

New treatments for multiple sclerosis and inflammatory arthritis approved Read more »

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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 »

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July 22, 2018 – The American Food and Drug Administration (FDA) just approved Ivosidenib (Tibsovo) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation in the IDH1 gene.  It is …

Ivosidenib (Tibsovo) for AML-patients with IDH1-mutations Read more »

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June 28, 2018 – The American Food and Drug Administration (FDA), a couple of week ago, approved Erenumab-Aooe (Aimovig) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Erenumab-Aooe (Aimovig) is the first FDA-approved …

Erenumab-Aooe (Aimovig): Novel preventive treatment for migraine approved Read more »

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January 13, 2018 – The American Food and Drug Administration (FDA) has just approved the first treatment for breast cancer with a certain inherited genetic mutation. At first glance, this announcement may be just one in the series of announcements by the …

Olaparib Tablets (Lynparza): For breast cancer with BRCA gene mutation Read more »

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December 25, 2017 – The American Food & Drug Administration (FDA) has approved two genetic tests to identify genetic alterations in tumors.  The FoundationOne CDx (F1CDx) genomic test and the MSK-IMPACT Tumor Profiling test both can help to guide physicians in …

FDA-cleared genomic profiling tests to guide cancer treatment Read more »

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November 17, 2017 – The American Food & Drug Administration (FDA) just approved  Vestronidase alfa-vjb (Mepsevii),  the first treatment for pediatric and adult patients with the inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII …

Treatment for the rare genetic disorder MPS VII approved Read more »

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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 …

The first gene therapy FDA approved in the US Read more »

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