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Enasidenib was approved for medical use in the United States in August 2017. [ 2 ] [ 4 ] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication . [ 5 ]
Raltegravir (Isentress), developed by Merck & Co., was the first INSTI approved by the FDA in October 2007.; Elvitegravir (Vitekta), licensed by Gilead Sciences from Japan Tobacco, was approved by the U.S. Food and Drug Administration in August 2012, for use in adults starting HIV treatment for the first time as part of the fixed dose combination with emtricitabine and tenofovir disoproxil ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Olutasidenib is indicated for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. [2] [3] [4]
Ionis Pharmaceuticals, Inc. is a biotechnology company based in Carlsbad, California, that specializes in discovering and developing RNA-targeted therapeutics.The company has three commercially approved medicines: Spinraza (), Tegsedi (), and Waylivra (Volanesorsen), and has four drugs in pivotal studies: tominersen for Huntington's disease (together with Roche), tofersen for SOD1-ALS, AKCEA ...
The FDA advises the treating physician should monitor the Ryoncil infusion, and discontinue it if there is any evidence of a reaction such as shortness of breath, low blood pressure, fever, or ...
Lilly’s Zepbound, approved in November 2023 as the Indiana-based drug giant’s answer to Novo Nordisk’s Wegovy, showed 21% average weight loss after 72 weeks for its highest dose in its Phase ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...