EMA has recommended granting a conditional marketing authorisation for Carvykti (ciltacabtagene autoleucel) and it is now pending for European Commission decision.Medicines for human use are eligible for conditional marketing authorisation if…
Today, from Revio, we would like to share with you a summary of the International Council for Harmonisation (ICH) guideline about nonclinical biodistribution considerations for gene therapy products. This draft…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)