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EU MDR, FDA, CE Regulations

FDA Leaders Set Bold Course on AI, Drug Review, and Industry Independence in JAMA Publication

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SHERIDAN, WYOMING – June 12, 2025 – In a strategic move signaling regulatory reform and modernization, FDA Commissioner Marty Makary and CBER Director Vinay Prasad have outlined a new four-year roadmap for the agency in The Journal of the American Medical Association (JAMA). Their article, “Priorities for a New FDA,” introduces a reform-focused agenda that emphasizes accelerated drug approval timelines, generative AI implementation, and a renewed focus on cost transparency and public health outcomes.

FDA Approves Roche’s VENTANA MET (SP44) RxDx Assay as First Companion Diagnostic for Emrelis Treatment in NSCLC

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SHERIDAN, WYOMING – May 27, 2025 – Roche has announced FDA approval of its VENTANA® MET (SP44) RxDx Assay, marking a major milestone in companion diagnostics for non-small cell lung cancer (NSCLC). This approval paves the way for a more precise identification of patients eligible for AbbVie’s Emrelis™ (telisotuzumab vedotin-tllv), a targeted therapy for non-squamous NSCLC with MET protein overexpression.

Enhancing Treatment Precision in Lung Cancer Care