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…
Scientific Explorer: EMA’s AI Tool to Improve Scientific Advice
On March, the European Medicines Agency (EMA) launched a new tool based in Artificial Intelligence (AI) for EU regulators. Scientific Explorer simplifies the daily work of the scientific staff involved…
New Cellular Therapy for Unresectable or Metastatic Melanoma Approved by FDA
Today, from Revio, we are thrilled to share that the U.S. Food and Drug Administration recently approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of patients with…
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…
FDA Releases New Guidance on Potency for Cell and Gene Therapy Product
Today, we at Revio are excited to share that the Food and Drug Administration (FDA) has announced the availability of a new draft guidance, titled "Potency Assurance for Cellular and…
EMA–FDA Joint Q&A on Quality and GMP Aspects of PRIME/Breakthrough Therapy Applications 22-01-2024
The EMA’s PRIority MEdicines (PRIME) scheme and the FDA’s Breakthrough Therapy (BT) designation program are designed to expedite the development of innovative products that address unmet medical needs. However, the…
EMA Approves First Gene Therapy for Beta Thalassemia 9-01-2024
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.…
European Commission’s Medical Device Coordination Group (MDCG) Raises Alarm Over Scarce MDR and IVDR Applications
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…
Awareness Session for SMEs on the Reform of EU Pharmaceutical Legislation
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…
FDA Approves First Treatment for Rare Inherited Blood Disorder
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…
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