The FDA approval of etripamil for PSVT occurred in December, 2025. Investigation about a potential role of etripamil in ...

The problem isn't that fewer women get aortic stenosis. It's that the entire pipeline, from diagnosis to device, was built ...

Nature Medicine's Validation Accords push for a generative AI consensus framework, and expose a regulatory gap that could invalidate trial data if ...

Rentosertib becomes first AI-discovered drug in Phase III trial for IPF, testing lung-function decline over 52 weeks across 47 Chinese sites.

Seismic Pharmaceuticals enrolls first patient in Phase 3 trial of istaroxime for cardiogenic shock, the only late-stage program targeting this deadly condition.

Live site initiation visits should focus on protocol-specific content that creates operational risk, per Christine Senn's framework for SIV training design.

PSI CRO presents agile models emerging biotech sponsors can use to scale global trials while maintaining operational control at OCT New England.

Tyra Biosciences selects 60mg dose of dabogratinib in NMIBC Phase 2 Study, advancing oral FGFR3 inhibitor development for bladder cancer treatment.

FDA grants Priority Review to Roche's Enspryng for MOGAD after Phase III trial showed 68% reduction in relapse risk versus placebo.

CONSONANCE's digitally enhanced MS endpoint cut required sample size 24.9%. Here's what that number costs in protocol ...

Advarra releases IRB reportable events checklist to help research teams distinguish critical safety signals from minor ...

A Nature Biotechnology phase 2a trial ran six proteomic aging clocks simultaneously, here's what that means for biomarker ...