These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

164 related articles for article (PubMed ID: 36261044)

  • 1. First conditional marketing authorization approval in the European Union for hemophilia "A" gene therapy.
    VandenDriessche T; Pipe SW; Pierce GF; Kaczmarek R
    Mol Ther; 2022 Nov; 30(11):3335-3336. PubMed ID: 36261044
    [No Abstract]   [Full Text] [Related]  

  • 2. Use of the conditional marketing authorization pathway for oncology medicines in Europe.
    Hoekman J; Boon WP; Bouvy JC; Ebbers HC; de Jong JP; De Bruin ML
    Clin Pharmacol Ther; 2015 Nov; 98(5):534-41. PubMed ID: 26080745
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021.
    Vokinger KN; Kesselheim AS; Glaus CEG; Hwang TJ
    JAMA Health Forum; 2022 Aug; 3(8):e222685. PubMed ID: 36200635
    [TBL] [Abstract][Full Text] [Related]  

  • 4. ADA-SCID Gene Therapy Endorsed By European Medicines Agency For Marketing Authorization.
    Ylä-Herttuala S
    Mol Ther; 2016 Jun; 24(6):1013-1014. PubMed ID: 27324442
    [No Abstract]   [Full Text] [Related]  

  • 5. Time to Entry for New Cancer Medicines: From European Union-Wide Marketing Authorization to Patient Access in Belgium, Estonia, Scotland, and Sweden.
    Ferrario A
    Value Health; 2018 Jul; 21(7):809-821. PubMed ID: 30005753
    [TBL] [Abstract][Full Text] [Related]  

  • 6. An open science pathway for drug marketing authorization-Registered drug approval.
    Naudet F; Siebert M; Boussageon R; Cristea IA; Turner EH
    PLoS Med; 2021 Aug; 18(8):e1003726. PubMed ID: 34370737
    [TBL] [Abstract][Full Text] [Related]  

  • 7. A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU.
    da Costa Gonçalves F; Demirci E; Zwiers A
    Clin Transl Sci; 2022 Aug; 15(8):1959-1967. PubMed ID: 35561071
    [TBL] [Abstract][Full Text] [Related]  

  • 8. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.
    Coppens DGM; de Wilde S; Guchelaar HJ; De Bruin ML; Leufkens HGM; Meij P; Hoekman J
    Cytotherapy; 2018 Jun; 20(6):769-778. PubMed ID: 29730080
    [TBL] [Abstract][Full Text] [Related]  

  • 9. A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines.
    Garsen M; Steenhof M; Zwiers A
    Ther Innov Regul Sci; 2021 Jul; 55(4):633-642. PubMed ID: 33543409
    [TBL] [Abstract][Full Text] [Related]  

  • 10. EU marketing authorization review of orphan and non-orphan drugs does not differ.
    Putzeist M; Mantel-Teeuwisse AK; Llinares J; Gispen-De Wied CC; Hoes AW; Leufkens HG
    Drug Discov Today; 2013 Oct; 18(19-20):1001-6. PubMed ID: 23835230
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Gene Therapy Briefs.
    Philippidis A
    Hum Gene Ther Clin Dev; 2018 Dec; 29(4):172-175. PubMed ID: 30576249
    [No Abstract]   [Full Text] [Related]  

  • 12. Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU.
    Demirci E; Omes-Smit G; Zwiers A
    Clin Transl Sci; 2023 Jul; 16(7):1127-1133. PubMed ID: 37013379
    [TBL] [Abstract][Full Text] [Related]  

  • 13. [Marketing authorization for pharmaceuticals: the necessity of European collaboration].
    Seitz R; Enzmann H
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2008 Jul; 51(7):703-4. PubMed ID: 18592336
    [No Abstract]   [Full Text] [Related]  

  • 14. Guidelines on similar biologics: regulatory requirements for marketing authorization in India.
    Rathore A
    PDA J Pharm Sci Technol; 2012; 66(5):393. PubMed ID: 23035022
    [No Abstract]   [Full Text] [Related]  

  • 15. Approval probabilities and regulatory review patterns for anticancer drugs in the European Union.
    Hartmann M; Mayer-Nicolai C; Pfaff O
    Crit Rev Oncol Hematol; 2013 Aug; 87(2):112-21. PubMed ID: 23433721
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Gene therapy for hemophilia.
    Nathwani AC
    Hematology Am Soc Hematol Educ Program; 2022 Dec; 2022(1):569-578. PubMed ID: 36485127
    [TBL] [Abstract][Full Text] [Related]  

  • 17. [EU law on marketing authorization of medicines. History, current state of development and perspectives].
    Nettesheim M
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2008 Jul; 51(7):705-12. PubMed ID: 18560781
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
    Iglesias-Lopez C; Obach M; Vallano A; Agustí A
    Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
    [TBL] [Abstract][Full Text] [Related]  

  • 19. European Medicines Agency Perspective on Oncology Study Design for Marketing Authorization and Beyond.
    Jonsson B; Martinalbo J; Pignatti F
    Clin Pharmacol Ther; 2017 May; 101(5):577-579. PubMed ID: 28073148
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Changing standards for drug approval: A longitudinal analysis of conditional marketing authorisation in the European Union.
    Hoekman J; Boon W
    Soc Sci Med; 2019 Feb; 222():76-83. PubMed ID: 30605802
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.