AI-powered prognostics used in histopathology can reveal complex patterns in tissue and cells that exceed human vision capabilities. We present how the incorporation of these models into laboratory workflows creates more objective, reproducible, and scalable processes. This affords greater diagnostic accuracy, faster turnaround times, and patient care that best fits their needs. By handling variability and subjectivity in traditional methods, this approach supports more confident prognoses and better clinical outcomes.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.
The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.