Recently, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending the grating of a market authorization of two different Advanced Therapy Medicinal Products (ATMPs).…
New EMA Reflection paper on the evaluation of New Active Substance status of biological substances Recently, the EMA has published a new reflection paper reflecting the current experience on New…
FDA has recently issued a new final Guidance for Industry on Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial. The purpose of this…
EMA has recommended granting a marketing authorisation in the European Union for Upstaza (eladocagene exuparvovec). This is a gene therapy for the treatment of adult and paediatric patients with severe…
Today, from Revio, we would like to share with you the latest updates on the scientific recommendations that European Medicines Agency’s Committee for Advanced Therapies (CAT) delivers on whether a…
Today, from Revio, we would like to share with you a summary on a recent draft guidance document published by the US Food and Drug Administration (FDA): “Considerations for the…
The European Medicines Agency (EMA) has accepted to review the Marketing Authorisation Application (MAA) for etranacogene dezaparvovec (EtranaDez), a gene therapy to treat hemophilia B, under its accelerated assessment procedure.…
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…
In the development of an Advanced Therapy Medicinal Product (ATMP) involving the donation of human tissues or cells to be used as starting materials, the control of the materials, traceability,…
Today, for the Rare Disease Day, from Revio we would like to share the following information regarding the European Medicines Agency (EMA) orphan designation procedure for medicines for rare diseases.An…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)