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...
Aavantgarde Presents Updated LUCE-1 Data at Euretina 2025
No new efficacy or safety numbers were disclosed. Still, AAVantgarde Bio will present updated Phase 1/2 LUCE-1 data for...
Veeva and IQVIA: A New Era of Collaboration in Clinical Trials
In a transformative move, Veeva Systems and IQVIA, two titans in the life sciences sector, have shifted from litigation...
Anavex Publishes Blarcamesine Autophagy Study Results
Anavex Life Sciences has published preclinical data in •iScience• further elucidating the mechanism by which its SIGMAR1 (S1R) agonist,...