The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses
PiNACLE is a head-to-head study comparing its next-generation CAR T-cell therapy against established therapies liso-cel and axi-cel in patients with relapsed or refractory large B-cell lymphoma
The acquisition brings Lilly a novel in vivo cell therapy platform built around engineered circular RNA and proprietary lipid nanoparticles
The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation
Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas
The one-time CAR T cell infusion now becomes the first and only therapy of its kind cleared for this patient population
Capstan's lead asset, CPTX2309, is a targeted lipid nanoparticle (tLNP) that delivers an mRNA encoding an anti-CD19 chimeric antigen receptor (CAR) to CD8-expressing cytotoxic T cells in vivo
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
CMG1A46 is an investigational T cell-engager with potential to deeply deplete uncontrolled B cells present in autoimmune diseases such as lupus
Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile
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