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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 ... -
REPROCELL Accelerates Clinical Production with FDA/EMA/PMDA-Compliant iPSC Manufacturing Platform
REPROCELL Japan Overview REPROCELL has unveiled a robust iPSC manufacturing scale-up strategy aimed at accelerating clinical development and commercialization of iPSC-based therapeutics. Their StemRNA™ Clinical iPSC Platform offers clini... -
REPROCELL Publishes Article on Scaling iPSC Manufacturing: Addressing Challenges from Cell Line Development to Clinical Production
REPROCELL Japan Overview REPROCELL has published an article titled "Scaling iPSC Manufacturing: From Cell Line Development to Clinical Production," focusing on the crucial aspects of industrializing induced pluripotent stem cell (iPSC) t... -
Hereditary Transthyretin Amyloidosis Market: Intellia/Regeneron’s CRISPR Gene Editor Nexiguran ziclumeran Receives FDA RMAT Designation
GlobeNewswire USA Overview This article summarizes a market research report by DelveInsight on the hereditary transthyretin amyloidosis (hATTR) market. The report highlights Nexiguran ziclumeran (nex-z), a CRISPR-Cas9-based gene-editing ... -
FDA Expands CASGEVY Pediatric Indication: CRISPR Gene-Editing Therapy Evaluated for Sickle Cell Disease and Transfusion-Dependent Beta-Thalassemia in 5-11 Year Olds
HCA Healthcare Today USA Overview The FDA expanded approval for CASGEVY (exagamglogene autotemcel), a CRISPR-based gene-editing therapy for sickle cell disease and transfusion-dependent beta-thalassemia, to eligible patients aged 2 years... -
Ocugen Doses First Patient in Phase 3 Registrational Trial for OCU410 Modifier Gene Therapy for Geographic Atrophy, Following RMAT Designation
GlobeNewswire USA Overview Ocugen has initiated patient dosing in its Phase 3 registrational trial for OCU410, a modifier gene therapy targeting geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). OCU410 rece... -
Fate Therapeutics Initiates Phase 2 RECLAIM-LN Trial for Lupus Nephritis with Off-the-Shelf iPSC-Derived CD19 CAR-T Cell Therapy FT819
Seeking Alpha USA Overview Fate Therapeutics has commenced its Phase 2 RECLAIM-LN trial for lupus nephritis, administering the first patient with its iPSC-derived CD19 CAR-T cell therapy, FT819, in an outpatient setting. This marks a sig... -
August Sees Mixed Fortunes in Gene Therapy: Ultragenyx’s GSDIa Therapy Gets Accelerated Approval, Epicrispr Raises $90M, While REGENXBIO’s RGX-121 Faces Clinical Hold
Vertex AI Search USA Overview August 2026 brought both significant advancements and setbacks in the next-generation therapeutics space. Ultragenyx secured FDA accelerated approval for GENGLYCOS, a gene therapy for GSDIa, offering a new o... -
FDA Expands Regulatory Flexibility for Cell and Gene Therapies, Streamlining CMC Requirements to Accelerate Early Clinical Development
Medicinova, Inc. (Facebook) USA Overview The US FDA has announced an expansion of regulatory flexibility for Cell and Gene Therapy (CGT) products, particularly adapting Chemistry, Manufacturing, and Controls (CMC) requirements across the... -
US States Restrict Cultivated Meat Labeling, Intensifying Legal Conflict Over Food Policy and Federal Approval
Food Policy Watch (Facebook repost) USA Overview Several U.S. states are imposing restrictions on the labeling of federally approved cultivated meat products, escalating a legal conflict between state and federal food policies. States li...
