iPS Cells & Regenerative Medicine– category –
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Exosome Treatments in Aesthetics Remain FDA Unapproved with Safety Warnings: Emphasizing Evidence-Based Approaches
Aesthetic Med Guide USA Overview The U.S. FDA has reiterated that no exosome products are approved for aesthetic purposes and has issued a public safety alert against the use of unapproved products. This article details the scientific ba... -
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... -
FDA Issues Draft Guidance to Streamline Regulatory Submissions for Cell and Gene Therapy Products by Leveraging Prior Knowledge
Pharmuni USA Overview The U.S. FDA has released new draft guidance aimed at accelerating the development of cell and gene therapy products for rare diseases. This guidance permits developers to leverage existing scientific, manufacturing... -
Stem Cell Therapies for Parkinson’s Disease Advance to Clinical Stages: BlueRock’s Phase 3 and Japanese iPSC Program Lead the Way
NeurologyLive USA Overview Stem cell therapies for Parkinson's Disease, particularly dopamine cell replacement trials, are making significant strides into advanced clinical stages. BlueRock Therapeutics' embryonic stem cell (ESC)-derived... -
BioCardia’s CardiAMP Autologous Cell Therapy Accelerates Towards Global Approval for Heart Failure
MerlinTrader (BioCardia分析) USA Overview BioCardia's CardiAMP autologous bone marrow cell therapy for cardiovascular disease has achieved significant regulatory milestones. The U.S. FDA confirmed that the ongoing Phase 3 CardiAMP Heart ... -
Intellia Therapeutics’ Lonvo-z Anticipates Key Phase 3 HAE Data Presentation at EAACI 2026
Simply Wall St USA Overview Intellia Therapeutics highlighted that additional data from the Phase 3 HAELO trial of lonvo-z (lonvoguran ziclumeran), its CRISPR-based therapy for hereditary angioedema (HAE), will be presented at the Europe... -
Beam Therapeutics’ Gene-Editing Candidate BEAM-302 Shows Positive Clinical Data in AATD Treatment, Hinting at Accelerated FDA Pathway
Simply Wall St USA Overview Beam Therapeutics reported positive clinical trial data for its gene-editing candidate, BEAM-302, demonstrating sustained protective protein levels in the treatment of Alpha-1 Antitrypsin Deficiency (AATD). Th... -
Century Therapeutics’ iPSC-Derived Type 1 Diabetes Therapy CNTY-813 Demonstrates Durable Glucose Control and Immune Evasion in Preclinical Studies
BioSpace (Century Therapeutics) USA Overview Century Therapeutics announced groundbreaking preclinical data for its iPSC-derived islet replacement therapy, CNTY-813, designed for Type 1 Diabetes (T1D) with Allo-Evasion™ 5.0 technology, a... -
Allogeneic BCMA CAR T Therapy CB-011 Achieves Deep Responses and Confirms Immune Cloaking in Multiple Myeloma Phase 1 Trial
The ASCO Post USA Overview CB-011, the first allogeneic anti-BCMA CAR T-cell therapy incorporating immune cloaking technology, achieved a high overall response rate (ORR) in its Phase 1 CaMMouflage trial for relapsed/refractory heavily p... -
Caribou Biosciences’ Off-the-Shelf Allogeneic CAR T Vispa-cel Shows Superior PFS to Approved Autologous CAR T Therapies in Lymphoma Phase 1
Fierce Biotech USA Overview Caribou Biosciences announced promising median progression-free survival (PFS) data from its Phase 1 clinical trial of vispacabtagene regedleucel (vispa-cel), an off-the-shelf allogeneic CAR T-cell therapy for...
