MRD Is Now the Endpoint That Matters: The EMN24 IsKia Trial Just Proved It
The EMN24 IsKia phase 3 trial didn't just test a new drug combination for newly diagnosed multiple myeloma —...
Moe Alsumidaie
The Basket Trial Is the New Black — and the FDA Hasn’t Caught Up
Arrowhead Pharmaceuticals' Phase 1 basket trial of zodasiran enrolled five distinct lipid disorder populations under a single protocol —...
The FDA Just Opened a Door in Anal Cancer Trials — And Most Sponsors Don’t Know It’s There
Oncolytics Biotech's Type C meeting request to discuss a single-arm registrational pathway for pelareorep in anal cancer is more...
The Alzheimer’s Prevention Trial Has No Finish Line — Until Now
A new set of target product profiles published in Nature Medicine attempts to define what a successful preventive Alzheimer's...
The GLP-1 Pill Just Broke Every Obesity Trial Playbook
The FDA's approval of oral orforglipron for obesity isn't just a formulation win — it's a structural disruption to...
The EMA’s Virtual Control Group Gambit Could Redraw the Map for Pivotal Trial Design
The EMA has opened consultation on a draft qualification opinion for virtual control groups — a methodology that, if...
The Trial That Should Rewrite the Rare Disease Playbook — But Probably Won’t
AstraZeneca's Phase 3 benralizumab trial in hypereosinophilic syndrome just delivered one of the cleanest efficacy signals in rare disease...
The POLAR Trial Proves Pancreatic Cancer Trials Were Broken by Design
The POLAR trial's Phase 2 results in homologous-recombination-deficient metastatic pancreatic cancer aren't just a clinical win — they're an...
The Bone and Muscle Safety Gap That GLP-1 Megastudies Weren’t Designed to Fill
Lilly and Novo have already won the weight-loss efficacy war. The next drug approval battle is being fought on...
The Wearable Gap: Why Sensors Are Outrunning the Trials That Use Them
Wearables are generating physiological data at a scale clinical trials have never seen before. But a March 2026 review...