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FDA’s Innovative Approach to Global Gene Therapy Collaboration
In a landmark move, the FDA has initiated the Collaboration on Gene Therapies Global Pilot (CoGenT), signaling a significant leap toward worldwide collaboration in the field of gene therapy. This pilot aims to enable concurrent collaborative reviews of new gene therapy applications with global regulators…
FDA issues new draft guidelines on potency assurance for cell and gene therapy products
In this draft guidance, the FDA emphasizes that potency assays and their corresponding acceptance criteria should be designed to make meaningful contributions to potency assurance by reducing risks to product potency. They provide illustrative examples of approaches to potency assay development that are...
The FDA’s approval of Casgevy and Lyfgenia represents a transformative moment in the evolution of gene therapy
In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has approved two revolutionary treatments, Casgevy and Lyfgenia, marking a significant milestone in the field of gene therapy. These therapies represent the first-ever cell-based gene treatments for sickle cell disease (SCD) in patients...
Gene Therapy Analytical Development & mRNA Assay Development Summits – 2023
We are excited to announce that Avance Biosciences™ will be attending the highly anticipated Gene Therapy Analytical Development Summit and the mRNA Assay Development Summit, and we cordially invite you to join us! As a leader in development and validation of assays for advanced therapies...
A Historic Milestone as UK Regulatory Body Approves Revolutionary CRISPR Treatment
In a landmark decision that could reshape the landscape of medicine and treatment, the United Kingdom has granted approval for the first-ever CRISPR therapy, Casgevy. This groundbreaking development marks a significant stride in the field of genetic medicine and opens up new possibilities for treating a range of...
CRISPR-Based Therapy Analytical Development Summit – 2023
We are thrilled to announce that Avance Biosciences™ will be attending the highly anticipated CRISPR-Based Therapy Analytical Development Summit, and we cordially invite you to join us! As a leader in advanced therapies, we understand the importance of staying at the forefront of gene therapy innovation...