FDA– tag –
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FDA Manufacturing PreCheck Pilot Program Selects 7 Companies Including Cellares to Streamline and Expedite Cell Therapy Manufacturing Processes
RegMedNet UK Overview The FDA has selected seven companies, including Cellares Corp, FUJIFILM Biotechnologies, and Kriya Therapeutics, for its "Manufacturing PreCheck Pilot Program," designed to streamline cell and gene therapy manufactu... -
Capricor Therapeutics to Present Positive Five-Year HOPE-2 OLE Data and HOPE-3 Phase 3 Results for Deramiocel in Duchenne Muscular Dystrophy at PPMD 2026 Conference
GlobeNewswire (via Capricor Therapeutics) USA Overview Capricor Therapeutics announced it will present crucial clinical data on Deramiocel, its lead cell therapy candidate for Duchenne Muscular Dystrophy (DMD), at the PPMD 2026 Annual Co... -
FDA Issues Over Six Warning Letters for Unapproved Exosome Therapies in US, Citing Illegal Sales and Unsubstantiated Claims (2024-2026)
Medical Spa Locator USA Overview As of June 2026, no injectable exosome products have received FDA approval in the United States. The FDA has issued over six warning letters between 2024 and 2026 to manufacturers and distributors selling... -
FDA Approves Orca-T, First Regulatory T-Cell Therapy to Improve Chronic GVHD-Free Survival in Blood Cancer Patients Undergoing Allogeneic HSCT
American Society of Clinical Oncology (ASCO) Post USA Overview The US FDA has approved Orca-T (Tregzi, Orca Bio), the first regulatory T-cell (Treg)-based immunotherapy to improve chronic graft-versus-host disease (GVHD)-free survival in... -
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... -
China’s NMPA Grants World’s First Approval for Solid Tumor CAR T-Cell Therapy Satri-cel Targeting CLDN18.2 Positive Gastric Cancer
OncLive USA Overview OncLive's June 2026 GI oncology regulatory roundup highlights China's NMPA approval of CARsgen Therapeutics' satricabtagene autoleucel (satri-cel), the first solid tumor CAR T-cell therapy for Claudin18.2-positive ad... -
Cellares’ Cell Shuttle Platform Accepted into FDA’s Inaugural Manufacturing PreCheck Cohort, First and Only Cell Therapy Platform to Receive Designation
BioSpace USA Overview Cellares announced its acceptance into the FDA's inaugural 'Manufacturing PreCheck Pilot Program,' as the sole cell therapy platform among seven companies nationwide. Its automated, end-to-end Cell Shuttle platform ... -
Vertex’s CRISPR Gene Therapy CASGEVY Gains Expanded FDA Approval for Sickle Cell Disease and Beta Thalassemia in Children Ages 2 and Older
Vertex Pharmaceuticals USA Overview Vertex Pharmaceuticals announced the US FDA has approved an expanded indication for its gene therapy, CASGEVY® (exagamglogene autotemcel), for treating sickle cell disease or transfusion-dependent beta... -
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... -
Exosome Clinical Trials Hit ~90 Globally in 2026: Advancing Regenerative Medicine, Diagnostic Biomarkers, and Drug Delivery
OmniGenix USA Overview A new peer-reviewed analysis in 2026 reveals approximately 90 exosome-related human clinical trials registered globally, showcasing diverse applications from cancer diagnostics to joint repair. Exosomes are being i...
