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December 2025 capped the year with a robust slate of FDA activity, including multiple final and draft guidances addressing labeling, safety reporting, clinical trials, and real-world evidence, alongside notable regulatory news and multiple drug and...
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Following the political agreement of 11 December 2025 on the EU Pharmaceutical Package, the summary below highlights the elements most relevant to clinical evidence generation and Joint Clinical Assessment (JCA) planning. This reform represents the most...
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Mergers and acquisitions (M&As) are a defining feature of today’s biopharmaceutical landscape. As companies merge pipelines, teams, and strategies, clinical development programs often undergo significant transitions. Yet during these shifts, one of the...
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Returning from the American Society of Hematology Annual Meeting in Orlando, one message was clear: hematology is entering a phase of rapid diversification. Across late-breaking abstracts, plenary sessions, and maturing follow-up data, ASH 2025 reflected...
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Developing therapies for neurological diseases represents one of the most challenging frontiers in modern biotechnology. With subjective clinical assessments, high variability in outcomes, and substantial investment requirements, neurology programs face...
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November brought significant FDA activity, with new final and draft guidances—from Pre-RFD updates to cross-center master files and Q3E leachables—alongside notable RAPS coverage, leadership changes, regulatory developments, and multiple high-impact drug...
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In the rapidly evolving field of circulating tumor DNA research, being on the front lines of clinical trials offers unparalleled insights into the future of cancer care. As Dr. Gabriela Rosu, Veristat’s Vice President, Global Medical Affairs, observes,...
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The promise of circulating tumor DNA for early cancer detection comes with a complex paradox: the very sensitivity that makes ctDNA valuable for catching cancer early also raises concerns about overdiagnosis and overtreatment. As Dr. Gabriela Rosu,...
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Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...