The European Medicines Agency (EMA) has recently recommended the approval of the first therapy based in CRISPR/Cas9, a groundbreaking gene-editing technology that earned its inventors the Nobel Prize in 2020.…
The European Parliament and Council's Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) have established a reinforced regulatory framework for medical devices and in vitro diagnostic medical devices. Their primary…
On November 24th, the European Medicines Agency (EMA), in collaboration with the European Commission, organized a webinar to clarify key aspects of the reform of EU pharmaceutical legislation, which was…
The U.S. Food and Drug Administration has recently approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic or on demand enzyme replacement therapy in adult and pediatric…
Today, from Revio, we would like to share an overview on the FDA’s scientific guideline to “Human Gene Therapy for Rare Diseases”, that provides recommendations on the manufacturing, preclinical, and…
Today from Revio we’re happy to announce a new pilot program developed by the U.S. Food and Drug Administration (FDA) to help further accelerate the development of novel drug and…
Revio is pleased to announce the upcoming 76th Cellular, Tissue, and Gene Therapies Advisory Committee scheduled for October 31, 2023, from 9:00am - 5:00pm ET. Before diving into the agenda…
Today from Revio we are sharing with you an overview on the FDA’s Guidance for Industry "Human Gene Therapy for Retinal Disorders". This document focuses on issues specific to gene…
Today, from Revio, we will provide an overview on the EMA’s Guideline on Xenogeneic Cell-Based Medicinal Products. This guideline offers general principles for the development of these types of products.…
FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes Recently, the FDA granted approval to the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)