Joseph Gut - thasso
Posted in Genetic Background, New Drug Approval, Pediatrics, Rare Diseases, Thasso Post, Theragenomic Medicine
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March 21, 2014 – (This post relayed from the FDA Press Release site. No editing; if any, copyrights remain with FDA or its respective holder(s)).
The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).
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Joseph Gut - thasso
Posted in Children, Genetic Predisposition, New Drug Approval, Personalized Medicine, Targeted Therapy, Thasso Post, Theragenomic Medicine
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May 29, 2019 – Spinal muscular atrophy (SMA) is a group of neuromuscular disorders that result in the loss of motor neurons and progressive muscle wasting. The severity of symptoms and age of onset varies by the type. Some types are apparent at or before birth while others are not apparent until adulthood.
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Joseph Gut - thasso
Posted in Allelic Variant, New Drug Approval, Regulatory Approval, Targeted Therapy, Thasso Post, Theragenomic Medicine
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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 2 (HER2)-negative,
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Joseph Gut - thasso
Posted in New Drug Approval, Regulatory Approval, Thasso Post, Theragenomic Medicine
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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 urgently need additional therapy options. FDA approves new oral treatment for multiple sclerosis
The FDA approved Cladribine (Mavenclad) tablets to treat relapsing forms of multiple sclerosis (MS ) in adults,
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Joseph Gut - thasso
Posted in New Drug Approval, Rare Diseases, Thasso Post, Theragenomic Medicine
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February 07, 2019 – The American Food and Drug Administration (FDA) just approved Caplacizumab-yhdp (Cablivi), the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP),
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Joseph Gut - thasso
Posted in New Drug Approval, Rare Diseases, Thasso Post, Theragenomic Medicine
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January 12, 2018 – Fabry disease is an inherited disorder caused by mutations (alterations) in the alpha-galactosidase A (GLA) gene located on the X-chromosome. Fabry disease is rare and affects both males and females. It is estimated that classic Fabry disease (the most severe type) affects approximately one in 40,000 males.
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Joseph Gut - thasso
Posted in New Drug Approval, Rare Diseases, Thasso Post, Theragenomic Medicine
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Joseph Gut - thasso
Posted in New Drug Approval, Rare Diseases, Regulatory Announcement, Thasso Post, Theragenomic Medicine
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Joseph Gut - thasso
Posted in New Drug Approval, Personalized Medicine, Targeted Therapy, Thasso Post, Theragenomic Medicine
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October 31, 2018 – The American Food and Drug Administration (FDA) recently approved Cemiplimab-Rwlc (Libtayo) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
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