Tenaya’s TN-201 Gene Therapy Shows Cardiac Remodeling in MYBPC3-HCM Trial
TN-201 gene therapy reduces left ventricular mass and wall thickness in MYBPC3-HCM patients, with five of six achieving NYHA...
Obexelimab Meets Primary Endpoint in Phase 3 IgG4-RD Trial, BLA Submitted
Obexelimab met its primary endpoint in Phase 3 IgG4-RD trial with 56% flare risk reduction, prompting FDA BLA submission...
PROTEUS Trial: Apalutamide Plus ADT Cuts Metastasis Risk in Prostate Cancer
Apalutamide plus ADT reduced metastasis risk by 20% in high-risk prostate cancer, with nine times higher pathologic response than...
FDA Accepts Pharming’s Leniolisib Resubmission for Children 4-11 With APDS
FDA accepts Pharming's leniolisib resubmission for children 4-11 with APDS, targeting October 2026 decision after resolving manufacturing documentation issues.
DBV Technologies Launches THRIVE Trial of VIASKIN Peanut Patch in Infants
DBV Technologies launches THRIVE trial of VIASKIN Peanut Patch in infants ages 6–12 months with confirmed peanut allergy, targeting...
Ziftomenib Plus Venetoclax/Azacitidine Shows Strong Response in R/R NPM1-Mutated AML
Ziftomenib plus venetoclax/azacitidine achieved 70% composite complete remission in venetoclax-naïve R/R NPM1-mutated AML patients, with rapid response and mana
Obexelimab Meets Primary Endpoint in Phase 3 IgG4-RD Trial
Obexelimab Phase 3 IgG4-RD trial hits primary endpoint with 56% flare reduction and significant steroid-sparing benefits in largest study...
Nipocalimab Shows 58% Response Rate in Autoantibody-Positive SLE Patients
Nipocalimab shows 58% response rate in autoantibody-positive SLE patients in Phase 2 JASMINE trial, with sustained benefit at Week...
Apalutamide Cuts Metastasis Risk 20% in Prostate Cancer Surgery Trial
Apalutamide reduced metastasis risk by 20% in the Phase 3 PROTEUS trial of prostate cancer surgery patients with high-risk...
FDA Accepts NDA for Roche’s Giredestrant in Early-Stage Breast Cancer
FDA accepts Roche's giredestrant NDA for early-stage breast cancer with 30% reduction in recurrence or death in phase III...