BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

626 related articles for article (PubMed ID: 35389145)

  • 1. Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA.
    Michaeli DT; Mills M; Michaeli T; Miracolo A; Kanavos P
    Invest New Drugs; 2022 Aug; 40(4):798-809. PubMed ID: 35389145
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
    Salcher-Konrad M; Naci H; Davis C
    Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Overall Survival, Progression-Free Survival, and Tumor Response Benefit Supporting Initial US Food and Drug Administration Approval and Indication Extension of New Cancer Drugs, 2003-2021.
    Michaeli DT; Michaeli T
    J Clin Oncol; 2022 Dec; 40(35):4095-4106. PubMed ID: 35921606
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Cancer Drug Prices in the United States: Efficacy, Innovation, Clinical Trial Evidence, and Epidemiology.
    Michaeli DT; Michaeli T
    Value Health; 2023 Nov; 26(11):1590-1600. PubMed ID: 37516196
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.
    Michaeli DT; Michaeli T; Albers S; Boch T; Michaeli JC
    Eur J Health Econ; 2023 Nov; ():. PubMed ID: 37962724
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.
    Vokinger KN; Kesselheim AS
    BMJ Open; 2019 Oct; 9(10):e028634. PubMed ID: 31601584
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
    Alqahtani S; Seoane-Vazquez E; Rodriguez-Monguio R; Eguale T
    Pharmacoepidemiol Drug Saf; 2015 Jul; 24(7):709-15. PubMed ID: 26013294
    [TBL] [Abstract][Full Text] [Related]  

  • 8. FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis.
    Michaeli T; Jürges H; Michaeli DT
    BMJ; 2023 May; 381():e073242. PubMed ID: 37160306
    [TBL] [Abstract][Full Text] [Related]  

  • 9. To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016.
    Kühler TC; Bujar M; McAuslane N; Liberti L
    BMJ Open; 2019 Nov; 9(11):e028677. PubMed ID: 31772082
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia.
    Hwang TJ; Kesselheim AS; Tibau A; Lee CC; Vokinger KN
    JCO Oncol Pract; 2022 Sep; 18(9):e1522-e1532. PubMed ID: 35731996
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.
    Zhang AD; Puthumana J; Downing NS; Shah ND; Krumholz HM; Ross JS
    JAMA Netw Open; 2020 Apr; 3(4):e203284. PubMed ID: 32315070
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.
    Ghadanian M; Schafheutle E
    Ther Innov Regul Sci; 2024 Jan; 58(1):79-113. PubMed ID: 37861859
    [TBL] [Abstract][Full Text] [Related]  

  • 13. A Qualitative Study on the Differences Between Trial Populations and the Approved Therapeutic Indications of Antineoplastic Agents by 3 Regulatory Agencies From 2010 to 2018.
    Sumi E; Asada R; Lu Y; Ito-Ihara T; Grimes KV
    Clin Ther; 2020 Feb; 42(2):305-320.e0. PubMed ID: 32008723
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Value and Price of Multi-indication Cancer Drugs in the USA, Germany, France, England, Canada, Australia, and Scotland.
    Michaeli DT; Mills M; Kanavos P
    Appl Health Econ Health Policy; 2022 Sep; 20(5):757-768. PubMed ID: 35821360
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval.
    Cherla A; Naci H; Kesselheim AS; Gyawali B; Mossialos E
    JAMA Intern Med; 2021 Apr; 181(4):490-498. PubMed ID: 33616607
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021.
    Gupta R; Morten CJ; Zhu AY; Ramachandran R; Shah ND; Ross JS
    JAMA Health Forum; 2022 May; 3(5):e221096. PubMed ID: 35977259
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review.
    Goring S; Taylor A; Müller K; Li TJJ; Korol EE; Levy AR; Freemantle N
    BMJ Open; 2019 Feb; 9(2):e024895. PubMed ID: 30819708
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.
    Downing NS; Aminawung JA; Shah ND; Krumholz HM; Ross JS
    JAMA; 2014 Jan 22-29; 311(4):368-77. PubMed ID: 24449315
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.
    Dhodapkar M; Zhang AD; Puthumana J; Downing NS; Shah ND; Ross JS
    JAMA Netw Open; 2021 Jun; 4(6):e2113224. PubMed ID: 34110392
    [TBL] [Abstract][Full Text] [Related]  

  • 20. A cross-sectional study of the FDA approved indications and supporting pivotal trials of small-molecular kinase inhibitors in cancer therapies with the biomarker of cancer driver gene.
    Huang Y; Xiong W; Ma L; Wu H
    Int J Cancer; 2022 Dec; 151(12):2107-2114. PubMed ID: 35860988
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 32.