Fast Track– tag –
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Allogene’s Off-the-Shelf CAR T Cema-Cel Secures FDA RMAT and Fast Track for High-Risk LBCL First-Line Consolidation
OncLive USA Overview Allogene Therapeutics' off-the-shelf anti-CD19 CAR T-cell therapy, cemacabtagene ansegedleucel (cema-cel), received FDA Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for first-line consoli... -
Allogene’s Off-the-Shelf CAR T, Cema-Cel, Earns FDA RMAT and Fast Track for High-Risk LBCL First-Line Consolidation
Allogene Therapeutics, Inc. USA Overview Allogene Therapeutics has secured FDA Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for its investigational allogeneic CAR T-cell therapy, cemacabtagene ansegedleucel (... -
A2 Biotherapeutics’ CAR T-Cell Therapy A2B543 Receives FDA Fast Track Designation for Advanced Solid Tumors
OncLive USA Overview A2 Biotherapeutics Inc.'s autologous CAR T-cell therapy, A2B543, has been granted FDA Fast Track designation for adults with recurrent unresectable, locally advanced, or metastatic solid tumors who are HLA-A*02 posit... -
Top 10 Emerging Healthcare Technologies in 2026: CRISPR Gene Editing Established as Therapeutic Category, Regenerative Medicine Nearing Clinical Application
Slate USA Overview An article on 10 emerging healthcare technologies to watch in 2026 highlights that CRISPR gene editing is moving beyond the lab to become a bona fide therapeutic category. Additionally, regenerative medicine and stem c... -
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 Expedited Pathway Guide: Strategic Selection of Fast Track, Breakthrough Therapy, and RMAT
Boyd Consultants USA Overview The FDA offers several expedited programs to accelerate innovative drug development, including Fast Track, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy (RMAT). This article outlines the d... -
iRegene Therapeutics’ NouvNeu001 Secures Dual FDA Expedited Designations: A New Regulatory Milestone for iPSC Therapies
RegMedNet UK Overview iRegene Therapeutics announced its allogeneic iPSC-derived therapy, NouvNeu001, received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for Parkinson's disease, following its prior Fast ... -
Precision BioSciences Unveils Promising Preclinical Data for In Vivo Gene Editing Therapy in Duchenne Muscular Dystrophy
Morningstar USA Overview Precision BioSciences has presented encouraging preclinical data for PBGENE-DMD, an in vivo gene editing therapy targeting Duchenne Muscular Dystrophy, at the 2026 ASGCT Annual Meeting. Early intervention in youn...
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