Bempedoic Acid’s Triumph: A New Level 1A Recommendation
Topline: The 2025 ESC/EAS Focused Update assigns Class I, Level A support for non-statin therapies with proven cardiovascular benefit...
AMALFI Trial: Zio ECG Monitoring Increases AFib Diagnosis
AMALFI reported a 6.8% new AFib diagnosis rate with a single 14-day Zio long-term continuous monitoring patch, compared to...
RNA Polymerase I Clinical Trials: A Promising 2025 Report
No approved RNA Polymerase I inhibitors are on the market, but the lead asset, pindnarulex (CX-5461), has advanced into...
Surging Bispecific ADC Trials Signal – FDA Approval Wave
In early clinical data from a Phase 1 trial in esophageal squamous cell carcinoma, the bispecific antibody drug conjugate...
Celcuity to Submit Gedatolisib NDA in PIK3CA Wild-Type Cohort Under FDA’s RTOR Program
Gedatolisib delivered a hazard ratio of 0.24 for progression-free survival in the PIK3CA wild-type cohort of the Phase 3...
Telitacicept Succeeds in Phase 3 Trial for IgA Nephropathy
Telitacicept reduced the 24-hour urine protein-to-creatinine ratio by 55% compared to placebo at 39 weeks (p < 0.0001) in...
BXCL’s At-Home Igalmi Trial Meets Primary Endpoint
In the Phase 3 SERENITY At-Home trial, BXCL501 120 mcg met its primary endpoint of tolerability for self-administered treatment...
Report: Surging Bispecific ADC Trials Eye FDA Approval 2025
In early clinical testing for esophageal squamous cell carcinoma, the bispecific ADC izalontamab brengitecan reported a confirmed objective response...
Kyverna Spotlights New CAR T Trial for Myasthenia Gravis
Kyverna outlined a registrational path for KYV-101 in generalized myasthenia gravis (MG), converting its KYSA-6 study into a Phase...
Zevra to Unveil Multiple Arimoclomol Datasets at ICIEM Meet
In its pivotal Phase 3 study, arimoclomol (MIPLYFFA) halted disease progression versus placebo over 12 months on the NPC...