Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA Approvals.
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| Title: | Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA Approvals. |
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| Authors: | Saito K; Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan. kakuxchloe0109@gmail.com.; Clinical Development, Moderna Co., Ltd, Tokyo, Japan. kakuxchloe0109@gmail.com., Narukawa M; Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan. |
| Source: | Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2026 Jul; Vol. 60 (4), pp. 983-992. Date of Electronic Publication: 2026 Mar 17. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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