gene therapy products Archives

EMA positive opinion for new gene therapy to treat multiple myeloma

Post published:April 7, 2022

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…

Draft Guideline: ICH S12. Non clinical biodistribution considerations for gene therapy products

Post published:August 5, 2021

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…

EMA positive opinion for new gene therapy to treat multiple myeloma

Draft Guideline: ICH S12. Non clinical biodistribution considerations for gene therapy products

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