Regulatory News
Navigating the evolving landscape of drug development and regulatory compliance can be complex and challenging. From FDA guidance updates to international regulatory changes, staying informed is critical for researchers, biotech innovators, and pharmaceutical professionals. This page brings you a curated list of the most important news in drug development regulation, highlighting updates from the FDA, EMA, and other regulatory bodies around the world
Regulatory News
Navigating the evolving landscape of drug development and regulatory compliance can be complex and challenging. From FDA guidance updates to international regulatory changes, staying informed is critical for researchers, biotech innovators, and pharmaceutical professionals. This page brings you a curated list of the most important news in drug development regulation, highlighting updates from the FDA, EMA, and other regulatory bodies around the world.
The FDA is embracing AI to streamline drug reviews, aiming for full implementation by June 2025. Following a successful pilot, this move could fast-track therapy approvals and reduce administrative tasks for scientists...
The FDA is phasing out animal testing for monoclonal antibodies and other drugs, turning to AI, lab-grown human tissues, and global safety data to streamline development, cut costs, and improve patient safety...
Avance Biosciences offers CLIA-compliant testing services to ensure accurate, reliable data throughout drug development. From biomarker validation to regulatory support, our expertise helps biopharmaceutical companies advance clinical trials and bring innovative biologic treatments to market with confidence...
HOUSTON, Feb. 26, 2025 /PRNewswire/ -- Avance Biosciences, a leading provider of high-quality analytical and bioanalytical services for the pharmaceutical industry, is pleased to announce that it has successfully registered [...]
Tecelra is the first FDA-approved T cell receptor (TCR) gene therapy. The product is an autologous T cell immunotherapy composed of a patient’s own T cells. T cells in Tecelra are modified to express a TCR that targets MAGE-A4, an antigen expressed by cancer cells in synovial sarcoma...
Two hallmark toxicities of chimeric antigen receptor (CAR) T-cell therapy may be rare after 2 weeks following infusion in patients with diffuse large B-cell lymphoma (DLBCL), supporting a shorter, more flexible toxicity monitoring period, according to a recent study...
The guidance provides recommendations regarding information that should be provided in an investigational new drug (IND) application to assess the safety and quality of the investigational GE product, including information on product design, product manufacturing and testing, nonclinical safety...
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…
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...
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...
