Investigational New Drug– tag –
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ProBio’s AAV Manufacturing Excellence Accelerates UC Irvine and GlyTR Therapeutics’ Pan-Cancer CAR-T Program, Achieving 80% CAR Gene Insertion Efficiency
University of California, Irvine USA Overview ProBio's advanced AAV manufacturing technology is critically powering pre-IND research for the first-in-class pan-cancer CAR-T program developed by UC Irvine and GlyTR Therapeutics. ProBio's ... -
Cartherics to File IND for Ovarian Cancer iPSC-Derived NK Cell Therapy CTH-401 After Asia Pacific Award
Cartherics Pty Ltd Australia Overview Australian biotech Cartherics Pty Ltd was recognized as the Emerging Leader in Allogeneic Cell Therapy at the Asia Pacific Cell & Gene Therapy Excellence Awards 2026. Leveraging its proprietary g... -
UniXell’s iPSC-Derived Parkinson’s Therapy UX-DA003 Cleared for US Clinical Trials by FDA
Parkinson's News Today USA Overview UniXell Biotechnology has received FDA Investigational New Drug (IND) clearance for UX-DA003, an allogeneic iPSC-derived dopaminergic neural progenitor cell therapy for Parkinson's disease, enabling th... -
UniXell Biotechnology Secures US FDA IND Clearance for Off-the-Shelf Parkinson’s Cell Therapy UX-DA003, Accelerating Dual China-US Clinical Development
BioPharma APAC USA Overview UniXell Biotechnology announced that its allogeneic iPSC-derived therapy UX-DA003 for Parkinson's disease has received Investigational New Drug (IND) approval from the US FDA. This approval enables the company... -
Beam Therapeutics Gains FDA IND Approval for In Vivo Base Editing Therapy BEAM-304 for PKU
CRISPR Medicine News USA Overview Beam Therapeutics has received U.S. FDA Investigational New Drug (IND) approval for BEAM-304, an in vivo base editing therapy targeting phenylketonuria (PKU). This therapy utilizes adenine base editing d... -
Beam Therapeutics Receives U.S. FDA IND Clearance for BEAM-304, a Base Editing Therapy for Phenylketonuria (PKU)
Beam Therapeutics USA Overview Beam Therapeutics announced U.S. FDA Investigational New Drug (IND) clearance for BEAM-304, its investigational base editing therapy for Phenylketonuria (PKU). This milestone paves the way for human clinica... -
Cell Therapy Weekly: uniQure Plans BLA Submission for Huntington’s Gene Therapy AMT-130; Ernexa Prepares IND for iMSC, Autolus Reports Early Phase I Data for SLE CAR-T
Cell & Gene Therapy Insights USA Overview uniQure plans to submit a Biologics License Application (BLA) for AMT-130, a gene therapy for Huntington's disease, in Q3 2026, based on three-year Phase I/II data. Ernexa Therapeutics has comple... -
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 ... -
Century Therapeutics Unveils CNTY-813 iPSC-Derived Islet Replacement Preclinical Data at ADA 2026: Demonstrates Durable Glucose Control, Immune Evasion, and Scalable Manufacturing, IND Filing Expected Q4 2026
BioSpace (via GlobeNewswire) USA Overview Century Therapeutics presented new preclinical data for its iPSC-derived islet replacement therapy, CNTY-813, at the ADA 2026 Scientific Sessions. The data demonstrated durable glucose control, i... -
Lonza Unveils Enhanced DNA-to-IND Biologics Manufacturing Offering with 6-Month Timelines, Introducing GS Ori-Go™
PharmaSource Switzerland Overview Lonza has announced an enhanced 'DNA-to-IND' offering for biologics, aiming to achieve IND-readiness for monoclonal antibody programs in as little as six months. This accelerated timeline is supported by...
