Functional Concept
Cartesian reveals long-term mid-stage data for cell therapy in myasthenia gravis
Autologous Anti-BCMA-CAR-mRNA-transfected CD8+ T-lymphocytes, Myasthenia Gravis, Cell Therapy, Long-term, Cartesian
FDA official said to step in and pause review of Novavax’s COVID-19 vaccine
United States Food and Drug Administration, COVID19 (disease), Vaccines, Novavax ‘s, Review [Publication Type], Novavax, Approved
Neurona nabs $102M to launch pivotal trial of epilepsy cell therapy
MTLE, Epilepsy, Cell Therapy, RMAT, Identifier, drug-resistant
FDA okays Novartis’ second IgA nephropathy therapy Vanrafia
Vanrafia, United States Food and Drug Administration, Approved, Novartis, IGA Glomerulonephritis, Proteinuria
Cellares’ cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA
Cell Therapy, Advanced Manufacturing Technology, United States Food and Drug Administration, Technology, Identifier, Cell Shuttle, production, Cellares, Biologics License Application, Investigational New Drugs
Sanofi adds new inflammatory target to growing Nurix tie-up
Nurix, sanofi, Target, STAT6 protein, human, cellular targeting, Collaboration, Inflammation, Autoimmune Diseases, TRANSCRIPTION FACTOR, DEL-AI
Atsena reels in $150M to advance work on ocular gene therapies
Atsena, Retinoschisis, Juvenile, X-Linked, United States Food and Drug Administration, Dependovirus, Cloning Vectors, Hereditary, Retinal Diseases, Blindness, ATSN-201, ATSN-101
Patient suffers side effect in Cabaletta autoimmune CAR-T trial, but analysts unfazed
Systemic Scleroderma, Lupus Erythematosus, Systemic, Cabaletta, cell-associated neurotoxicity, Adverse effects, analysts, Autoimmune Diseases, CAR-T therapy, reSET (device), aspects of adverse effects, Cytokine Release Syndrome
Mass Firings at FDA Spark Concerns Over Agency’s Future
FDA, layoffs, leadership changes, public health, drug regulation, Trump administration
AIRNA nets $155M series B to launch clinical test of RNA editing tech
RNA Editing, Airna, AIR-001, RNA