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Posted in Genetic Background, Genetic Predisposition, Personalized Medicine, Pharmacogenetics, Regulatory Approval, Targeted Therapy, Thasso Post, Theragenomic Medicine
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Thus, FDA permits marketing, with special controls,
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thassodotcom
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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thassodotcom
Posted in Adverse Drug Reaction [ADR], New Research, New Safety Information, Thasso Post, Theragenomic Medicine
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October 21, 2018 – In a study published online September 13 in JAMA Oncology, the authors just reminded us of the fact that besides all hype about immune checkpoint inhibitors (ICIs) in the cancer therapy field,
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thassodotcom
Posted in Adverse Drug Reaction [ADR], New Safety Information, Rare Diseases, Thasso Post, Theragenomic Medicine
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01 September 2018 – The American Food and Drug Administration (FDA) is warning that cases of a very rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.
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thassodotcom
Posted in Genetic Background, New Drug Approval, Rare Diseases, Targeted Therapy, Thasso Post, Theragenomic Medicine
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August 14, 2018 – The American Food and Drug Administration (FDA) just approved Patisiran (Onpattro) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients.
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thassodotcom
Posted in Adverse Drug Reaction [ADR], Allelic Variant, Genetic Susceptibility, In The Press, Personalized Medicine, Thasso Post, Theragenomic Medicine
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thassodotcom
Posted in Allelic Variant, Companion Test, New Drug Approval, Personalized Medicine, Regulatory Approval, Targeted Therapy, Thasso Post, Theragenomic Medicine
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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.
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thassodotcom
Posted in New Drug Approval, Regulatory Approval, Thasso Post, Theragenomic Medicine
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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 preventive migraine treatment in a new class of drugs that work by blocking the activity of the calcitonin gene-related peptide receptor (CGRPR) for the prevention of migraine.
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thassodotcom
Posted in Genetic Background, Genetic Predisposition, New Drug Approval, Rare Diseases, Thasso Post, Theragenomic Medicine
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June 26, 2018 – The American Food and Drug Administration (FDA) just approved Cannabidiol (Epidiolex), for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe forms of epilepsy, in patients two years of age and older.
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