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This July 2026 regulatory update focuses on the FDA finalizing six guidances that addresses antiviral next-generation sequencing data, psychedelic drug trials, topical corticosteroid bioequivalence, and broader cancer-trial eligibility, while issuing...
China is rapidly becoming one of the most influential forces in global drug development—but bringing innovative therapies to patients worldwide requires more than scientific progress. It requires a regulatory strategy built for global success.
AI is changing clinical development, but speed alone isn't enough. In a regulated industry, every output still has to be accurate, traceable, and ready to withstand regulatory scrutiny.
That's the central theme of Veristat’s Kyle McBride's recent...
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This June 2026 regulatory update focuses on advancing innovative drug development through updated guidance on model-informed development, gene therapies, clinical trial design, and evidence generation. Key regulatory trends included increased use of AI,...
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June 22, 2026
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Antibody-drug conjugates — or ADCs — are not new. The concept of a "magic bullet" that delivers a cytotoxic payload directly to a tumour cell was articulated by Paul Ehrlich over a century ago. Gemtuzumab ozogamicin, the first modern ADC, received its...
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March 18, 2024
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Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs) are regulatory submissions needed for the initiation of clinical trials, and these applications have commonalities and differences throughout the world. If clinical...
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Would your drug development program benefit from partnering with experts in scientific and medical communications and publications? Perhaps we should first address what exactly scientific and medical communications and publishing entail.As medical...