Fast Track– tag –
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BrainChild Bio Secures $116M, Earns FDA Breakthrough Designations for CAR-T Therapy Against Pediatric Brain Cancer DIPG
Hoodline USA Overview BrainChild Bio, a biotechnology firm spun out of Seattle Children's Hospital, has raised $116 million to advance its novel CAR-T cell therapy for Diffuse Intrinsic Pontine Glioma (DIPG), a devastating pediatric brai... -
T-MAXIMUM Allogeneic CAR T-Therapy MT027 Receives FDA Fast Track Designation for Recurrent Glioblastoma
PR Newswire USA Overview T-MAXIMUM PHARMACEUTICAL announced that its B7-H3-targeted allogeneic CAR T-cell therapy, MT027, has received Fast Track Designation (FTD) from the U.S. FDA for the treatment of recurrent glioblastoma. MT027 had ... -
Xellsmart Secures FDA Fast Track Designation for Parkinson’s iPSC-Derived Cell Therapy, Accelerating CNS Pipeline
Longevity.Technology UK Overview Xellsmart announced its allogeneic, off-the-shelf iPSC-derived cell therapy for Parkinson's disease has received FDA Fast Track designation, expected to accelerate its development program. Specializing in... -
Allogene Therapeutics’ TALEN-Edited Lymphoma Cell Therapy cema-cel Receives FDA RMAT and Fast Track Designations, Achieves 58.3% MRD Negativity in Phase 2 Trial
PRISM MarketView USA Overview Allogene Therapeutics' TALEN-edited allogeneic cell therapy, cema-cel, has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, accelerating its regulatory pa... -
China’s Hopstem Biotech Secures Nearly RMB 200 Million in Series C First Close to Advance iPSC Cell Therapy Pipeline Led by hNPC01
Insight, China's Pharmaceutical Industry China Overview China's Hopstem Biotech has completed the first close of nearly RMB 200 million (approximately $27.5 million USD) in Series C funding to advance its iPSC cell therapy pipeline, led ... -
China’s Xellsmart Secures FDA Fast Track for Off-the-Shelf Stem Cell Therapy XS411 in Parkinson’s Disease, Demonstrating Efficacy in Early-Stage Patients in Chinese Phase 1/2 Trial
Endpoints News China Overview China-based Xellsmart's off-the-shelf stem cell therapy, XS411, for Parkinson's disease, has received FDA Fast Track designation. XS411 aims to replace lost dopamine-producing neurons and restore neurologica... -
Allogene Therapeutics’ Off-the-Shelf CAR-T Cema-cel Achieves 58.3% MRD Negativity in ALPHA3 Phase 2 LBCL Trial, Securing FDA RMAT and Fast Track Designations
Allogene Therapeutics, Inc. (Press Release) USA Overview Allogene Therapeutics announced strong Q2 2026 results, highlighting that its off-the-shelf CAR T-cell therapy, cema-cel, achieved a robust 58.3% minimal residual disease (MRD) neg... -
XellSmart Secures FDA Fast Track Designation for Off-the-Shelf iPSC-Derived Cell Therapy XS411 for Parkinson’s Disease
BioSpace (XellSmart) USA Overview XellSmart announced that its allogeneic, off-the-shelf iPSC-derived cell therapy candidate, XS411, for Parkinson's disease has received Fast Track Designation (FTD) from the U.S. FDA. XS411 aims to repla... -
FDA Details Regenerative Medicine Advanced Therapy (RMAT) Designation Framework, Offering Fast Track and Breakthrough Therapy Benefits
Global MedTech Expert USA Overview Global MedTech Expert details the FDA's regulatory framework for 351/361 HCT/P classification and Regenerative Medicine Advanced Therapy (RMAT) designation. RMAT offers significant benefits, including F... -
Hopstem’s iPSC-Derived Neural Progenitor Cell hNPC01 Receives FDA IND Clearance and Fast Track Designation for Stroke and Traumatic Brain Injury
AllSci USA Overview Hopstem Biotechnology announced that its allogeneic iPSC-derived forebrain neural progenitor cell therapy, hNPC01, received both IND clearance and Fast Track designation from the U.S. FDA for treating chronic motor de...
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