A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)'s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics...
FDA. Advancing health through innovation: 2018 new drug therapy approvals https://www.fda.gov/media/120357/download (2019). Chen, E. Y., Joshi, S. K., Tran, A. & Prasad, V. Estimation of study time reduction using surrogate end points rather than overall survival in oncology clinical ...
With 54 new drugs and seven cellular and gene therapy products, the approvals by the US Food and Drug Administration (FDA) recovered 2023 from the 2022 dent back to the levels of 2020–2021. As in previous years of this annual review, we assign these new drugs to one of three levels o...
Reports on the U.S. Food and Drug Administration's approval of the drug therapy, Stalevo, for treatment of Parkinson's disease.EBSCO_AspBrown University Psychopharmacology Update
Vorasidenib has been approved by the U.S. Food and Drug Administration (FDA) for patients with Grade 2 gliomas with IDH1 or IDH2 mutations
In clinical trials, AbbVie's risankizumab-rzaa produced high rates of durable skin clearance – most people (82 and 81%) treated with the drug achieved 90% skin clearance (PASI 90) at 1 year, with the majority (56 and 60%) achieving complete skin clearan
“New drugs” are defined as new chemical drugs, new biological products, gene and cell therapies, new vaccines, and new traditional Chinese medicines approved for the first time in mainland China. Chemical drugs accounted for the largest proportion of new drug approvals (72, or 69.2%), ...
Yoshitomi, S. et al. Quinidine therapy and therapeutic drug monitoring in four patients with KCNT1 mutations. Epileptic Disord. 21, 48–54 (2019). Article PubMed Google Scholar Mullen, S. A. et al. Precision therapy for epilepsy due to KCNT1 mutations: a randomized trial of oral quinidin...
The New Drug Approvals of 1996, 1997, and 1998: Drug Development Trends in the User Fee Era. Kenneth I. Kaitin,Elaine M. Healy. Drug Information ... KI Kaitin,EM Healy - 《Clinical Pharmacology & Therapeutics》 被引量: 122发表: 1999年 The New Drug Approvals of 1993, 1994,&1995: ...
AstraZeneca Vice President, Head of Breast Cancer Franchise, Discusses Impact of Truqap Approval FDA Grants Fast Track Designation to Adicet Bio’s CAR T-cell Therapy for Systemic Lupus Erythematosus Davy James February 5th 2025 Article The FDA has granted Fast Track Designation to Adicet Bio’s ...