Rogaratinib’s 41.7% Response Rate in SDH-Deficient GIST Rewrites the Playbook for Epigenetically Driven Trial Design
A 24-patient Phase 2 trial of rogaratinib hit 41.7% partial response in SDH-deficient GIST—a tumor that imatinib cures just...
The FDA Said No. Europe Said Yes. Someone Is Wrong About Camizestrant.
AstraZeneca's Etcamah won EMA approval weeks after FDA adcom rejection—exposing a regulatory split that demands answers on endpoint standards...
Akeso’s Ivonescimab OS Data From HARMONi-6 Selected for ASCO Plenary
Akeso's ivonescimab OS data from HARMONi-6 heads to ASCO plenary as a head-to-head Phase III trial against tislelizumab in...
TaiMed’s TMB-365/380 HIV Study Completes Phase 2b Enrollment Early
TaiMed's TMB-365/380 HIV Study completes Phase 2b enrollment ahead of schedule with viral suppression data matching expectations after two...
The Cancer Nobody Saw Coming: What One Gene Therapy Tumor Tells Us About a Broken Safety Surveillance System
A rare gene therapy-linked cancer case exposes fatal gaps in long-term safety monitoring—and why FDA's 15-year follow-up mandate isn't...
Infex’s RESP-X shows reduced exacerbations in Phase IIa bronchiectasis trial
RESP-X shows reduced exacerbations in Phase IIa bronchiectasis trial, with 100% target coverage and lung penetration confirmed.
Tedopi Plus Pembrolizumab Improves Survival in Platinum-Resistant Ovarian Cancer
Tedopi Plus Pembrolizumab Improves Survival in Platinum-Resistant Ovarian Cancer with HR of 0.53 in Phase 2 trial.
Novartis Presents IgA Nephropathy and C3 Glomerulopathy Data at ERA 2026
Novartis presents 2.5-year eGFR data from ALIGN trial of atrasentan in IgA Nephropathy, alongside iptacopan and zigakibart findings in...
LUMA trial of BIIB122 misses primary endpoints in Parkinson’s disease study
LUMA trial of BIIB122 failed to slow Parkinson's disease progression in 648 participants despite confirmed target engagement over 144...
BioCardia’s CardiAMP Shows 179-Second Exercise Gain in Refractory Angina Trial
BioCardia's CardiAMP shows 179-second exercise gain in refractory angina trial, with sustained angina reduction over two years of follow-up.