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AI in healthcare delivery
New research presented at an oncology meeting reported that patients who interact with an AI avatar doctor before an in-person visit can better understand their cancer treatment and experience...
Cancer biology: aging and metastasis mechanism
Georgetown Lombardi Comprehensive Cancer Center researchers identified RAGE as a mechanistic link between aging and worse breast cancer metastatic behavior. In mouse models and analyses of human...
CAR T patient selection biomarkers
New data suggested that naïve CD4+ T cells can predict success in CAR T-cell therapy for large B-cell lymphoma. The report focused on why real-world outcomes vary widely despite the platform’s...
Immunology in neurodegeneration (ALS)
Northwestern University Feinberg investigators mapped a peripheral-to-central immune cascade in ALS using integrated single-cell and spatial transcriptomics. In the Nature Neuroscience paper, the...
Gene therapy vectors for hemophilia
A new preclinical gene therapy study reported efficacy gains for liver-targeted AAV8 vectors in hemophilia A. Researchers evaluated HMR-001 and a codon-optimized variant, HMR-001z, and reported...
Immuno-oncology: MYC and tumor DNA repair
Oregon Health & Science University (OHSU) researchers reported that the cancer-driving MYC protein directly contributes to DNA repair mechanisms used by tumor cells under genotoxic stress. The...
Company operations: FDA clinical hold and rare disease development
Aardvark Therapeutics said it is seeking a path forward after the FDA placed its Prader-Willi syndrome program under clinical hold. The full hold halted all tests of the company’s small-molecule...
Funding and startups: payer intelligence platform
Anomaly raised $17 million for an AI-powered payer intelligence platform aimed at improving payer-related workflow and strategy for healthcare stakeholders. The round was led by Sound Ventures,...
FDA approval ties ctDNA MRD testing to bladder cancer immunotherapy
The FDA approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza as adjuvant therapy for muscle-invasive bladder cancer patients with circulating tumor DNA after cystectomy, using...
Phase 3 telitacicept interim data strengthens IgA nephropathy case
RemeGen reported a prespecified interim analysis from a Phase 3 program evaluating telitacicept in adults with biopsy-proven IgA nephropathy and persistent proteinuria. In the 318-patient study,...
Aardvark Therapeutics faces FDA clinical hold for Prader-Willi drug after volunteer cardiovascular issue
The FDA placed Aardvark Therapeutics’ ARD-101 drug for Prader-Willi syndrome under a clinical hold, pausing the company’s trials after a cardiovascular concern emerged in a safety study in healthy...
Gene and RNA therapy sector shows rebound in Q1 2026 landscape report
ASGCT’s Q1 2026 landscape report, presented by CEO David Barrett with support from Citeline, points to a “rebounding sector” for gene and RNA therapies. The report highlights 42 gene therapies...
Telitacicept aside—regulatory uncertainty grips US leadership at FDA after Makary exit
After FDA Commissioner Marty Makary resigned, Reuters reported that Tracy Beth Høeg, MD, PhD, who has been leading CDER, is expected to leave the agency as well, citing internal plans from...
Precision oncology expands with MYC biology spotlight in urothelial carcinoma
Researchers described a mechanistic role for MYC overexpression in urothelial carcinoma, linking the cancer-driving protein to clinical behavior, the tumor microenvironment, and treatment...
Gene therapy vector research advances hemophilia A with improved AAV8 delivery
A study reported new bioengineered AAV8 vectors, HMR-001 and codon-optimized HMR-001z, designed to enhance liver gene delivery in hemophilia A. The work aims to restore hemostasis in a condition...
Clinical-stage development: CRBN-mediated molecular glue targets ALK fusion NSCLC as TRI-611 enters Phase 1/2
TRI-611 entered Phase 1/2 evaluation for ALK-positive non-small cell lung cancer after receiving FDA Fast Track designation. The candidate is described as a CNS-penetrant CRBN-mediated molecular...
Microbiome-to-liver axis: pharmabiotic Phocaeicola dorei reverses cholestatic fibrosis via efferocytosis
Researchers reported that the gut bacterium Phocaeicola dorei may ease progression of cholestatic liver fibrosis by modulating immune cell function through efferocytosis. The team led by Eom,...
AI-enabled drug and trials matching partnership targets trial access gap in oncology
Massive Bio partnered with Just Worldwide to streamline clinical trial matching and patient intake for oncology studies. The collaboration pairs Massive Bio’s SYNERGY-AI™ platform with Just...
Precision oncology gets a new FDA approval pathway
The FDA approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza as adjuvant treatment for muscle-invasive bladder cancer patients whose circulating tumor DNA (ctDNA) remains positive...
Rare disease drug development stalls under FDA clinical hold
Aardvark Therapeutics’ Phase 3 program for its Prader-Willi syndrome metabolic drug ARD-101 was placed on full FDA clinical hold, halting ongoing testing. The hold follows cardiovascular concerns...