EMA’s SME Office 2023 Annual Report
We're excited to announce the publication of the EMA SME Office's 2023 annual report. This document outlines the Office's functions and their alignment with the needs of European small and…
EMA’s concept paper on phage therapies for human health
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 recommends authorisation of first therapy to treat rare genetic disorder
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 positive opinion for new gene therapy to treat multiple myeloma
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…
COVID-19 vaccines and treatments approved by the EMA
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…
