The CHMP’s November Verdict: Seven Approvals, Eleven Extensions, and a Post-Approval Evidence Burden That Sponsors Underestimate
EMA's CHMP recommended 7 new medicines and 11 label extensions in November 2026, pushing its 2026 total to 79...
Jade Biosciences Advances JADE101 Phase 3 Timeline for IgA Nephropathy
Jade Biosciences accelerates JADE101 Phase 3 timeline for IgA nephropathy, with the EVERGREEN trial starting in Q4 2026.
Rocket Pharma’s RP-A501 Danon Trial Gains FDA Alignment on Endpoints
Rocket Pharma's RP-A501 Danon trial gains FDA alignment on dual endpoints for accelerated approval, with topline results expected mid-2028.
Vivani Medical’s NPM-139 Implant Trial Set to Report Phase 1 Data
Vivani Medical's NPM-139 Implant Trial set to report Phase 1 data on a once- or twice-yearly semaglutide delivery system...
31% of Clinical Trial Sites Report Delays From Document Inconsistencies
31% of clinical trial sites report document inconsistencies causing start-up delays that push activation timelines back by weeks.
Eledon Tegoprubart Phase 3 Kidney Transplant Trial Opens as Cash Runway Extends to Q2 2027
Eledon's Phase 3 kidney transplant trial opens with tegoprubart targeting non-inferiority to tacrolimus in rejection prevention and graft survival.
Cardiff Oncology Onvansertib Phase 2 Data Shows 21-Month Durability in mCRC
Cardiff Oncology's onvansertib Phase 2 data demonstrates 21-month durability in metastatic colorectal cancer, with median PFS not yet reached...
What the P2P Platform Trial Gets Right About Site Readiness That Most Sponsors Get Wrong
The Path to Prevention trial embeds Phase 2A learning cohorts inside PPMI's 7,755-participant infrastructure, here's what that means for...
A Child Died in a Gene-Editing Trial No One Reported. China’s 1,033-Trial Experiment Is Running Faster Than Its Safety Net.
A 6-year-old died after an unreported gene-editing trial at Shanghai Xinhua Hospital. With 1,033 CGT IITs active in China,...
The 39-to-1 Ratio Hiding Inside Your Significance Threshold
At the FDA and Duke-Margolis rare disease workshop, a statistician unpacked what a one-sided 0.025 actually commits you to:...