FDA’s 2026 Single-Trial Default Standard Reframes the Dual-Pivotal Debate for Sponsors Still Designing Phase 3
FDA's 2026 shift to a single pivotal trial as the default approval standard forces sponsors to rethink Phase 3...
EMA
The EMA Just Opened a Door That Animal Testing Has Kept Closed for Decades
EMA's September 2026 NAM data pilot lets sponsors share organ-chip and computational data directly with regulators, reshaping preclinical drug...
What the PRAC’s June 2026 Valproate Meeting Highlights Actually Say About Paternal Exposure Risk
EMA's PRAC found paternal valproate exposure evidence "inconsistent" with causal NDD risk in offspring — but still recommended precautionary...
Ten Years of EMA Post-Authorization Data Reveal a System Running on Incomplete Evidence
A Nature Reviews Drug Discovery analysis of EMA post-authorization studies exposes systematic gaps in how conditional approvals convert to...
The CHMP’s May 2026 Output Signals a Structural Shift in European Drug Development — Sponsors Should Take Notes Now
EMA's CHMP recommended 8 new medicines and 13 indication extensions in May 2026—including camizestrant for ESR1+ breast cancer and...
Europe’s 2030 Clinical Trial Targets Are Already Falling Behind — And the Clock Is Ticking
EMA's first 2026 quarterly report shows only 40.5% of EU trials recruiting within 200 days — far below the...
Five Approvals, Nine Expansions: What the EMA’s April CHMP Meeting Reveals About Where Global Drug Development Is Heading
EMA's CHMP recommended 5 new medicines and 9 indication expansions in its April 20–23 meeting — here's what the...
AI Platform Predicts Clinical Trial Outcomes with High Accuracy
At the Clinical Trial Innovation Summit 2025 in Basel, QuantHealth's Chief Medical Officer presented AI-driven trial simulation technology capable...