FDA– tag –
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US FDA Reports Approximately 50% Approval Rate for Regenerative Medicine Advanced Therapy (RMAT) Designations, Totaling 193 Approvals Out of 388 Applications, Highlighting Accelerated Development in Regenerative Medicine
BioInformant (Blog) USA Overview According to a BioInformant blog post, the U.S. FDA has announced the approval of 193 out of 388 total Regenerative Medicine Advanced Therapy (RMAT) designation applications received to date. This indicat... -
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... -
FDA Approves Orca-T Precision Treg Cell Therapy, Reducing Chronic GVHD Risk and Boosting Survival in Blood Cancer Patients Undergoing Matched Donor Transplants
AJMC (American Journal of Managed Care) USA Overview The U.S. FDA has approved Orca-T precision Treg cell therapy, designed to reduce the risk of chronic graft-versus-host disease (GVHD) and improve survival rates in blood cancer patient... -
Bristol Myers Squibb’s First CELMoD Therapy ZENBEXUS™ (iberdomide) Receives FDA Accelerated Approval in Combination with Daratumumab for Multiple Myeloma Patients with Early Relapse
Bristol Myers Squibb (Press Release) USA Overview Bristol Myers Squibb announced that its innovative CELMoD therapy, ZENBEXUS™ (iberdomide), received accelerated approval from the U.S. FDA for multiple myeloma, in combination with daratu... -
City of Hope Reports Groundbreaking Phase 1 Data for CD19 CAR T-Cell Therapy in High-Risk ALL Patients, Achieving 84% 18-Month Event-Free Survival with Low Toxicity
Evaluate (Oncology Newsletter) USA Overview Researchers at City of Hope presented pivotal Phase 1 data for a CD19 CAR T-cell therapy in acute lymphoblastic leukemia (ALL), demonstrating an impressive 84% 18-month event-free survival rate... -
Aspen Neuroscience’s Personalized Cell Therapy Sasineprocel (ANPD001) Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Parkinson’s Disease
Longevity.Technology USA Overview Aspen Neuroscience announced that sasineprocel (ANPD001), its personalized cell therapy for Parkinson's disease, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA... -
Century Therapeutics Targets Q4 2026 IND Submission for iPSC-Derived CNTY-813 in Type 1 Diabetes, Advances CAR-iT Cell Therapy CNTY-308 Towards Clinical Trials This Year
Century Therapeutics, Inc. (Press Release) USA Overview Century Therapeutics announced that it has completed its pre-IND meeting with the FDA for CNTY-813, an iPSC-derived cell therapy for Type 1 diabetes, targeting an Investigational Ne... -
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... -
CRISPR’s Clinical Horizon: Liv Hospital Report Maps 2026 FDA Landscape and Broad Therapeutic Potential
Liv Hospital Turkey Overview Liv Hospital has published a comprehensive review outlining the latest advancements in CRISPR gene-editing technology, emphasizing its revolutionary impact on medical treatments. The report highlights breakth... -
Fate Therapeutics Initiates Phase 2 Trial for iPSC-Derived Off-the-Shelf CAR T-Cell Therapy FT819 in Lupus Nephritis, Gains FDA IND Approval for Autoimmune FT839
Fate Therapeutics, Inc. (Press Release) USA Overview Fate Therapeutics reported significant advancements in its iPSC-derived off-the-shelf CAR T-cell immunotherapy pipeline, with the first patient dosed in the Phase 2 RECLAIM-LN study of...
