Amylyx’s avexitide meets Phase 3 endpoints in post-bariatric hypoglycemia trial
Amylyx's avexitide meets Phase 3 endpoints in post-bariatric hypoglycemia trial, offering the first FDA-backed treatment option for a condition...
NIH Just Killed the Training Ground for Clinical Trialists. The Damage Will Take a Decade to See.
NIH's Program Update 3 eliminates Independent Clinical Trial Required K awards — 573 active K23s affected. The clinician-scientist pipeline...
The EU Just Revoked Tavneos. What Did FDA Know During the Parallel Review?
EMA revoked Tavneos (avacopan) in August 2026 over GCP breaches in the pivotal ADVOCATE trial. FDA approved the same...
The 82x ROI Claim Every Oncology Sponsor Is About to Misread
Tufts CSDD puts 82x ROI on AI monitoring agents in Phase 3 oncology. Before sponsors restructure monitoring teams, sites...
FDA Has Authorized 1,500 AI Medical Devices. The Evidence for Most of Them Is Still Catching Up.
Over 1,500 AI-enabled medical devices have FDA authorization, yet rigorous RCT validation trails far behind. Here's the mechanism breaking...
WCG Report: Site Delays and Phase II Terminations Rise in 2025 Clinical Trials
Phase II trial terminations rose to 31% in 2025, driven by site delays and participant dropout. WCG report reveals...
AbelZeta Gets FDA IND Clearance for Prizlon-cel in Large B-Cell Lymphoma
AbelZeta obtains FDA IND clearance for Prizlon-cel, a bispecific CAR-T therapy targeting CD20/CD19 in large B-cell lymphoma, backed by...
The AI Validation Gap: Decision Support Tools Are Outrunning Their Own Evidence
AI clinical trial decision support is a $1.35B market growing at 12.5% annually—but FDA's draft ML guidance and real-world...
Meant Launches LegitScript-Certified GLP-1 Telehealth Platform with Coaching
Meant launches LegitScript-certified GLP-1 telehealth platform with coaching support and prescription services across all 50 states.
Skye Bioscience Acquires Redx Pharma, Exits Obesity for Fibrosis Focus
Skye Bioscience acquires Redx Pharma and exits obesity development to pivot toward fibrosis and oncology with $125M financing.