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The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. [4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Buntanetap. Buntanetap is an orally-administered small molecule inhibitor of several neurotoxic proteins that is under investigation in the treatment of Alzheimer's disease, frontotemporal dementia, chronic traumatic encephalopathy and Parkinson's disease. [1][2] It is the (+) enantiomer of phenserine, as the (-) enantiomer also has unwanted ...
Ivosidenib is an isocitrate dehydrogenase-1 inhibitor that works by decreasing abnormal production of the oncometabolite 2-hydroxyglutarate (2-HG), leading to differentiation of malignant cells. [8] Ivosidenib was approved for medical use in the United States in July 2018, [8][9][10][11] and in the European Union in May 2023. [6][12] The US ...
Satralizumab was approved for medical use in the United States in August 2020. [20] [14] [11] The FDA granted the application for satralizumab fast track and orphan drug designations. [6] The FDA granted the approval of Enspryng to Genentech Inc. [6] Satralizumab is the third approved treatment for NMOSD in the United States. [6]
Sorafenib, sold under the brand name Nexavar, [3] is a kinase inhibitor drug approved for the treatment of primary kidney cancer (advanced renal cell carcinoma), advanced primary liver cancer (hepatocellular carcinoma), FLT3-ITD positive AML and radioactive iodine resistant advanced thyroid carcinoma.
Formula. C3350H5070N906O1044S38. Molar mass. 75 958.99 g·mol −1. Luspatercept, sold under the brand name Reblozyl, is a medication used for the treatment of anemia in beta thalassemia and myelodysplastic syndromes. [5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [8]