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News about "FDA guidance"
FDA Approves Pfizer-BioNTech's XFG-Targeted COVID-19 Vaccine for 2026-27 Season
Pfizer and BioNTech’s updated Comirnaty XFG vaccine is set to begin shipping across the US following FDA approval for the 2026–27 COVID-19 season.
FDA Guidance | 31/08/2026 | By News Bureau | 173
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 | 134
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 | 182
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