FDA– tag –
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Beam Therapeutics Receives FDA IND Clearance for BEAM-304, Advancing Base Editing Therapy for Phenylketonuria (PKU) into Clinical Development
GlobeNewswire USA Overview Beam Therapeutics Inc. announced that the FDA has cleared its Investigational New Drug (IND) application for BEAM-304, a base editing therapy for Phenylketonuria (PKU). PKU is a rare genetic metabolic disorder ... -
uniQure Announces Plan for BLA Submission of Huntington’s Disease Gene Therapy AMT-130, FDA Accepts Phase 1/2 3-Year Data for Accelerated Approval
uniQure Press Release USA Overview uniQure has announced that the FDA agreed in a Type B meeting that 3-year analysis data from its Phase 1/2 trial of gene therapy AMT-130 for Huntington's Disease (HD) would be acceptable as primary evid... -
FDA Grants RMAT Designation to Cellectis’ Allogeneic CD22 CAR-T Lasme-cel for Relapsed/Refractory B-ALL
Targeted Oncology USA Overview The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Cellectis' lasmecabtagene timgedleucel (lasme-cel; UCART22), an allogeneic CD22-targeting CAR-T cell therapy, for relapsed/re... -
FDA Releases Draft Guidance to Streamline Gene Therapy Development, Aiming to Accelerate Access to Novel Therapies
BioProcess International USA Overview The FDA has issued draft guidance for gene therapy development, designed to streamline the process by enabling developers to leverage prior knowledge and platform data. This non-binding document from... -
FDA-Endorsed Process Analytical Technology (PAT) Revolutionizes Pharmaceutical Manufacturing Quality with Real-time Measurement
Technology Networks UK Overview This article elucidates Process Analytical Technology (PAT) as an FDA-endorsed framework for real-time measurement and control in pharmaceutical manufacturing. PAT fundamentally shifts quality assurance fr... -
Bioprocess Analytics Optimizes Biologics Manufacturing with Digital Twins and AI for Predictive Quality Control
World Pharma Today USA Overview This article highlights the strategic application of bioprocess analytics and advanced algorithms to optimize biologics manufacturing. By leveraging real-time data and sophisticated machine learning models... -
VIVEbiotech Scales In Vivo Gene Therapy Portfolio to 15 Programs, Securing Key FDA Clinical Trial Approvals
PharmaSource スペイン Overview Spanish CDMO VIVEbiotech has significantly expanded its in vivo lentiviral vector gene therapy portfolio to 15 programs, several of which have already secured regulatory clearance for clinical trials, inclu... -
Biomanufacturing Quality Control Transforms with Real-time PAT and AI Integration Under FDA ICH Q13 Guidance
Technology Networks UK Overview Process Analytical Technology (PAT) in biomanufacturing is undergoing a paradigm shift from endpoint testing to real-time, in-line measurement, driven by FDA's ICH Q13 guidance on continuous manufacturing,... -
Cellares and TScan Therapeutics Partner to Automate Manufacturing of TCR-T Therapy Candidate TSC-101 for Hematologic Malignancies, Accelerating Commercialization
OTC Markets (BusinessWire) USA Overview Cellares and TScan Therapeutics announced an agreement to evaluate the automated manufacturing of TSC-101, a TCR-T cell therapy candidate for patients with hematologic malignancies. This collaborat... -
IndexBox Forecasts 7-9% CAGR for Global Lactate Enzymatic Biosensors Market by 2035, Driven by POCT and Sports Wearables Demand
IndexBox USA Overview This article is an overview of a market research report published by IndexBox. The global lactate enzymatic biosensors market is projected to grow at a Compound Annual Growth Rate (CAGR) of 7-9% from 2026 to 2035. T...
