The concept paper on phage therapies for human health goal is to establish a scientific guideline for the pharmaceutical development and manufacture of bacteriophage medicinal products intended for the therapeutic…
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…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)