Fresenius Got a Warning Letter Six Months After the Complaints Started. That Gap Is the Real Problem.
FDA's August 2026 warning letter to Fresenius Kabi's Ogden, Utah plant exposes how sponsor oversight of CMOs fails long...
The Algorithm Passed Every Benchmark. The Patients Didn’t Notice.
A landmark Nature Medicine RCT found AI improved clinician decisions but not patient outcomes, exposing the fatal flaw in...
Clinical trial sites advised to build data infrastructure before deploying AI tools
Clinical trial sites should establish data infrastructure before deploying AI tools, according to industry experts and recent guidance on...
Ascendis to Present Navepegritide Infant Trial Data at ESPE 2026
Ascendis will present sentinel cohort data from the reACHin Trial of navepegritide infant trial at ESPE 2026, extending the...
The Mitochondrial Switch That Makes Drugs Different From Food
New Nature Neuroscience data shows MCU inhibition blocks drug reward without touching natural reward circuits, a mechanistic breakthrough for...
Fortrea’s $45M Phase I Grab Is Your Vendor Continuity Problem Now
Fortrea's $45M acquisition of Worldwide Clinical Trials' early-phase division reshapes Phase I site networks and vendor contracts for sponsors...
The 400-Member Protein Family That Neuroscience Has Almost Entirely Ignored
Nature Reviews Drug Discovery identifies SLC transporters as untapped CNS drug targets, but 97% remain undrugged, and trial designers...
Tekton Research Sites Enroll 60 Participants in Phase 2 Obesity Trial, Triple Goal
Tekton Research sites enrolled 60 participants in Phase 2 obesity trial, tripling their combined enrollment goal and demonstrating strong...
Myriad bioscaffolds show 0.7% deep infection rate in 411-patient soft tissue study
Myriad bioscaffolds demonstrated a 0.7% deep infection rate in soft tissue reconstruction across 411 patients, significantly below historical benchmarks.
Clover’s RSV-hMPV Vaccine Shows Antibody Rises in Phase 2 Trial
Clover's RSV-hMPV vaccine produced 6-to-9-fold antibody rises in Phase 2, with no immune interference and strong safety. Candidate targets...