1. FDA approves quizartinib for newly diagnosed acute myeloid leukemia. News release. July 20, 2023. Accessed July 20, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-quizartinib-newly-diagnosed-acute-myeloid-leukemia 2. Erba HP, Monetesinos P, Kim HJ, et al. Qui...
先前的研究表明,尽管美国FDA授权的新抗癌药物数量在2009年至2020年期间有所增加,但大约三分之二的新药要么是同类药物,要么是其他已批准疗法的适应症。根据北美或欧洲的药物监管、公共卫生或卫生技术评估机构提供的评级,2007-2017年在欧洲推出的新药中,只有不到三分之一被评为提供高水平的治疗益处。这一观察结果表明,...
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. FDA. September 20, 2024. Accessed November 15, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-bortezomib-lenalidomide-a...
Xylazine is not approved for use in humans and is increasingly found in illicit drug samples along with fentanyl. People using opioids may be unaware of its presence. The drug is reported to increase euphoria and can cause sedation, low blood pressure, and slower than normal heart rate. These...
The application of asciminib in newly diagnosed Ph+ CML in chronic phase has been granted priority review by the FDA.1 FDA priority review designation signals drugs that, if approved, would provide significant improvements to safety or efficacy over available treatments. With priority review, the ...
Only NTZ is currently approved by the FDA for cryptosporidiosis treatment. Its main mechanism of action depends on inhibition of the basic enzyme in the anaerobic metabolism pathway, pyruvate ferredoxin oxidoreductase78. However, it has limited cure rates, with the marked disadvantage of being unbenef...
Center is one of the first sites nationwide to have commercial access to TriClip and is the first hospital in Western United States to utilize the system since it was approved by the U.S. Food and Drug Administration (FDA). UC Davis also hosted clinical trials for the procedure in 2023. ...
Under FDA constraints, our dose of 1 gram/M2 (about 35 mg/kg) was far below nearly all in vivo studies in which salutary outcomes were reported (Supplementary Fig. 6). It is speculative as to the mechanism whereby the GABA/GAD tandem attenuated glucagon more than GABA alone. However...
The vote, at a meeting in Atlanta, Georgia, came after an announcement that the US Food and Drug Administration (FDA) had approved the vaccine, marketed asPrevnar 13. The agency approved the vaccine for active immunization of infants and children aged 6 weeks through 5 years againstStreptococcus...
New indication would be the first FDA-approved treatment regimen for newly diagnosed multiple myeloma based on a study with MRD-negativity as the primary endpoint RARITAN, N.J.,Sept. 30, 2024/PRNewswire...