Phase 3 study shows aQIVc superior to comparators in older adults
Phase 3 study shows aQIVc demonstrated superior immunogenicity against influenza strains in adults 50 and older, with responses sustained...
FDA Clears Prelude’s PRT13722 Phase 1 Trial in HR-Positive Breast Cancer
FDA clears Prelude's PRT13722 Phase 1 trial in HR-positive breast cancer, advancing the oral KAT6A degrader toward patient enrollment.
PSI CRO to Present Agile Models for Emerging Biotech at OCT New England
PSI CRO presents agile models emerging biotech sponsors can use to scale global trials while maintaining operational control at...
Senn Framework Targets Protocol-Specific Content for Live Site Initiation Visits
Live site initiation visits should focus on protocol-specific content that creates operational risk, per Christine Senn's framework for SIV...
Seismic Pharmaceuticals Enrolls First Patient in Phase 3 Trial of Istaroxime for Cardiogenic Shock
Seismic Pharmaceuticals enrolls first patient in Phase 3 trial of istaroxime for cardiogenic shock, the only late-stage program targeting...
Insilico Medicine Begins Phase III Trial of AI-Discovered Drug Rentosertib for IPF
Rentosertib becomes first AI-discovered drug in Phase III trial for IPF, testing lung-function decline over 52 weeks across 47...
Tyra Selects 60mg Dose of Dabogratinib in NMIBC Phase 2 Study
Tyra Biosciences selects 60mg dose of dabogratinib in NMIBC Phase 2 Study, advancing oral FGFR3 inhibitor development for bladder...
FDA Grants Priority Review to Roche’s Enspryng for MOGAD
FDA grants Priority Review to Roche's Enspryng for MOGAD after Phase III trial showed 68% reduction in relapse risk...
Advarra Releases IRB Reportable Events Checklist to Reduce Over-Reporting
Advarra releases IRB reportable events checklist to help research teams distinguish critical safety signals from minor deviations requiring prompt...
Nektar to Release 24-Week Off-Treatment Data for Rezpegaldesleukin in Alopecia Areata
Nektar will release 24-week off-treatment data for rezpegaldesleukin in alopecia areata, testing durability after dosing ends in the Phase...