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…
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…
The global effort on fighting the on-going COVID-19 pandemic, declared so by the World Health Organization in 11 March 2020, is bearing fruit. The endeavor made in the last year…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)