Business Trends– category –
-
Fate Therapeutics Executives Sell Shares Post-FDA IND Approval for Next-Gen Autoimmune CAR-T Candidate FT839, Market Anticipates Basket Trial Success
TipRanks USA Overview Fate Therapeutics executives engaged in significant insider stock sales following news of the U.S. FDA's Investigational New Drug (IND) approval for FT839, its next-generation off-the-shelf CAR-T candidate for autoi... -
FDA Warns Against Unapproved Stem Cell and Exosome Therapies, Approves Products Limited to Specific Blood Disorders
The Bridge Health & Recovery USA Overview The U.S. FDA has publicly warned against clinics marketing stem cell and exosome products with false or unsubstantiated claims. Currently, FDA-approved stem cell-based products are limited, prima... -
FDA Finalizes Flexible CMC Framework for Cell and Gene Therapy Approvals, Accelerating Personalized Medicine Regulatory Pathways
BioProcess International USA Overview The U.S. FDA finalized a flexible Chemistry, Manufacturing, and Controls (CMC) framework for cell and gene therapy (CGT) product approvals, releasing a guidance document on May 5, 2026. This framewor... -
CREATE Medicines Expands Targeted In Vivo CAR Platform via Monash University Partnership, Driving Cell-Type-Specific Delivery with Advanced LNP Technology
BioSpace Australia Overview CREATE Medicines has expanded its targeted in vivo CAR platform through a strategic research collaboration and exclusive license agreement with Monash University. This partnership leverages targeted lipid nano... -
FDA Approves Tregzi, First Regulatory T-Cell (Treg) Immunotherapy for Chronic GVHD Prevention, Expands Casgevy Indication to Pediatric Patients
Cell and Gene Therapy Catapult USA Overview On June 30, 2026, the U.S. FDA approved Tregzi, the first regulatory T-cell (Treg)-based immunotherapy designed to prevent chronic graft-versus-host disease (GVHD) and improve survival. Tregzi ... -
Liv Hospital Accelerates iPSC Therapy with Bioreactor Investment, Targeting Parkinson’s Disease
Liv Hospital Turkey Overview Liv Hospital is addressing the critical challenge of safe and efficient mass production of induced pluripotent stem cells (iPSCs) through a major investment in advanced bioreactor systems. This initiative aim... -
Porton Advanced Secures China NMPA Commercial Manufacturing License for CGT Products, Expanding CDMO Services from Process Development to Commercialization
Contract Pharma China Overview Porton Advanced has obtained a Class C drug manufacturing license from China's National Medical Products Administration (NMPA), enabling it to provide commercial contract manufacturing services for cell and... -
Resilience and Eli Lilly Expand Strategic Partnership with $750M Investment to Boost U.S. Manufactured Medicine Supply
Resilience USA Overview Resilience and Eli Lilly and Company have expanded their strategic partnership with a significant $750 million investment aimed at increasing the supply of critical medicines manufactured in the U.S. This investme... -
Catalent Expands AAV Gene Therapy Partnership with Taysha Gene Therapies, Securing Exclusive Commercial Manufacturing for Rett Syndrome Treatment TSHA-102
Pharma Manufacturing USA Overview Taysha Gene Therapies and CDMO Catalent have expanded their strategic partnership, designating Catalent as the exclusive commercial manufacturer for TSHA-102, an AAV-based gene therapy for Rett syndrome,... -
RoosterBio and Applied StemCell Partner to Scale iPSC-Based Bioprocess Solutions, Accelerating Cell Therapy Manufacturing
MD Tech Council (Facebook) USA Overview RoosterBio and Applied StemCell have formed a strategic partnership to scale iPSC-based bioprocess solutions, aiming to accelerate the commercial production of cell therapies. This collaboration in...
