A peer-reviewed CIZ1B-FibA study reported 94% sensitivity and 97% negative predictive value in one early-stage lung cancer cohort, while identifying pre-analytic variability that must be resolved before broader clinical validation.
Beyond Air’s LungFit GO has received FDA Breakthrough Device designation for nontuberculous mycobacterial pulmonary disease after a 15-patient pilot showed high-dose nitric oxide could be self-administered at home.
Alumis’ 408-patient LUMUS study missed its primary and secondary endpoints in systemic lupus erythematosus, but prespecified interferon-high patients showed stronger responses that the company intends to discuss with regulators.
Ocugen has begun the 237-patient Phase 3 ArMaDa3 trial of OCU410, a one-time gene therapy for geographic atrophy after Phase 2 treatment reduced lesion growth by 31% at 12 months.
Novartis says oral BTK inhibitor remibrutinib significantly reduced relapse rates and MRI lesions versus teriflunomide in both Phase 3 REMODEL trials, with no liver safety signal and global regulatory filings now planned.
Abbott’s investigational TactiFlex Duo dual-energy ablation catheter delivered favorable 12-month results in the FlexPulse Global IDE study, supporting the company’s effort to secure U.S. FDA approval after receiving CE Mark in Europe.
Health Canada has issued Class II medical-device licenses for Fujirebio’s Lumipulse G pTau217 Plasma and NfL Blood assays, expanding automated blood-based neurological testing for Alzheimer’s pathology and neuro-axonal injury.
Jazz Pharmaceuticals says a second interim analysis of HERIZON-GEA-01 found statistically significant and clinically meaningful overall survival improvement with Ziihera plus chemotherapy versus trastuzumab plus chemotherapy in first-line HER2-positive advanced gastroesophageal adenocarcinoma.
Eli Lilly and Company says one-year Phase 3b data from TOGETHER-PsO and TOGETHER-PsA show sustained or deeper improvements when Zepbound and Taltz are used together in patients living with psoriatic disease and obesity.
The European Commission has approved AstraZeneca and Daiichi Sankyo’s Enhertu with pertuzumab for first-line HER2-positive metastatic breast cancer after DESTINY-Breast09 showed a 44% reduction in the risk of progression or death compared with long-standing THP therapy.