S. FDA approval of new drugs based on non-inferiority trials in oncology: a dangerous precedent? JAMA Oncol. 5, 607–608 (2019). Article Google Scholar Naci, H., Smalley, K. R. & Kesselheim, A. S. Characteristics of preapproval and postapproval studies for drugs granted accelerated ...
Methods The objective of this article was to map the clinical development of approved new oncology drugs in China from 2015 to 2021 and differed from previous studies by focusing on original new drugs, using the United States as a benchmark, and elaborating the endogenous features of clinical ...
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The Session was moderated by Dr. Yang Dajun, Vice-Chairman of PhIRDA Drug R&D Specialty Committee and Chairman of the Board & CEO of Ascentage Pharma and Director Li Wenbin, Vice-Chairman of PhIRDA Clinical Research Specialty Committee and Director of Dept of Neuro-oncology, Beijing Tiantan Hos...
Nature Reviews Clinical Oncology (Nat Rev Clin Oncol)ISSN1759-4782(online)ISSN1759-4774(print) Sign up for theNature Briefingnewsletter — what matters in science, free to your inbox daily. Email address Sign up I agree my information will be processed in accordance with theNatureand Springer ...
Through our Cogstate partnership, we use rapid and reliable digital cognitive assessments, along with ePROs, to gauge oncology drugs’ cognitive effects. This insight provides drug developers a competitive advantage, highlighting the therapy’s broader impact beyond tumor response. Commitment to speed ...
Food and Drug Administration (FDA) granted approval to a total of 55 new drugs, comprising 29 new chemical entities (NCEs) and 25 new biological entities (NBEs). These drugs primarily focus on oncology, the central nervous system, anti-infection, hematology, cardiovascular, ophthalmology, ...
Particularly as more drugs are introduced, these flaws delay evaluation of new drugs and increase their cost. While we address AML to elucidate some problems with phase 2 studies and to suggest some solutions, we believe our points are generally applicable. The cost and inefficiency of oncology ...
eTable 4. Oncology Drugs Converted to Regular Approval Since 2021 on the Basis of Response Rate or Response Rate Plus Duration of Response eTable 5. FDA-Required Postmarketing Commitments for Oncology Drugs Converted to Regular Approval Since 2021 on the Basis of Response Rate or Response Rate ...
Is health-related quality of life (HRQoL) reporting keeping pace with new drug approvals in hematology and oncology: A five-year analysis of 245 drug appro... 6519#Background:HRQoL data in cancer clinical trials can inform tolerability of new drugs, facilitate informed decision-making, and infl...