Phathom Completes Enrollment in Phase 2 Vonoprazan EoE Trial Ahead of Schedule
Phathom completes Phase 2 Vonoprazan EoE Trial ahead of schedule with 95 patients enrolled. Topline data expected by Q4...
When Your CRO’s AI Platform Upgrades, Who Pays for the Change Management?
Icon's Microsoft-Copilot partnership scales its Orbis AI platform enterprise-wide. For sites and sponsors mid-trial, the operational cost question starts...
GENFIT’s GNS561 Shows No Dose-Limiting Toxicities in Cholangiocarcinoma Phase 1b
GENFIT's GNS561 shows no dose-limiting toxicities in Phase 1b cholangiocarcinoma trial combining autophagy inhibition with MEK inhibition in KRAS-mutated...
Phathom Fills 95 Patients in a Disease With No Approved PPI: What the pHalcon-EoE-201 Enrollment Speed Reveals
Phathom enrolled 95 EoE patients across 41 U.S. sites ahead of schedule — in a disease where PPIs dominate...
FDA Rejects Cytisinicline NDA Over Manufacturing Issues, Not Safety
FDA rejected cytisinicline over manufacturing issues at a third-party facility, not clinical safety, with resubmission planned for Q4 2026.
When Your Sponsor Gets Acquired Mid-Trial, Your Site Pays the Operational Price
Lilly's $7.8B Centessa acquisition closes June 24—here's what site coordinators and ops leads must do before the IND transfers...
Revolution Medicines Opens RASolute 305 Trial of Zoldonrasib in RAS G12D Pancreatic Cancer
Revolution Medicines opens RASolute 305 Trial of zoldonrasib in RAS G12D pancreatic cancer, testing the G12D-selective inhibitor in the...
Obesity Trials Are Optimized to Win Approval, Not to Predict Real-World Use
Nature Medicine's 2026 analysis exposes why obesity drug trials maximizing weight loss endpoints produce results that collapse on contact...
Autonomous AI Agents Can Outperform Physicians. That’s Not the Hard Part.
MIRA beat physicians on diagnostic accuracy. AMIE matched them across 100 cases. Now comes the real test: whether regulated...
Zoll Medical’s FDA Warning Letter Reveals the QC Failure Sponsors Keep Funding
FDA's April 2026 warning letter to Zoll Medical exposes quality control and MDR violations at a cardiopulmonary device maker...