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News about "FDA guidance"
Aspen Neuroscience's Parkinson's Cell Therapy Receives US FDA RMAT Designation
Aspen Neuroscience has received US FDA Regenerative Medicine Advanced Therapy designation for sasineprocel (ANPD001), its investigational autologous cell therapy for Parkinson's disease.
FDA Guidance | 31/07/2026 | By News Bureau | 107
FDA Publishes Guidance on Modern Statistical Methods for Clinical Research
The FDA guidance provides a framework for applying Bayesian analyses in clinical research, enabling data-driven assessments of safety and efficacy using both current and prior evidence.
FDA Guidance | 14/01/2026 | By News Bureau | 136
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