FDA Grants Priority Review to BridgeBio’s Oral Infigratinib for Pediatric Achondroplasia
FDA grants priority review to BridgeBio's oral infigratinib for pediatric achondroplasia, offering a once-daily pill alternative to injections.
AI Is Now Running Clinical Trials. The Question Is Whether Anyone Is Watching.
From a cancer patient's self-built AI agent to ARPA-H's phaseless trial model, AI has crossed from analytics into operations....
Why Your Coverage Analysis Undercounts Imaging, And Audits Notice
When scan sets split into separate rows, MCAs lose the parent schedule. Here is what that costs you and...
Three of Four Deaths Were Called Unrelated. The FDA Still Saw a Signal
Newron's investigators assessed three of four evenamide deaths as unrelated. The FDA, looking at the same events pooled across...
Retatrutide’s TRIUMPH-2 Data Forces a Reckoning With How We Design Metabolic Trials
TRIUMPH-2's Phase 3 data on retatrutide in 1,152 T2D patients challenges every assumption sponsors hold about GLP-1 trial design...
eClinical Solutions hosts ENGAGE 2026 with 250+ attendees from 75+ life science firms
eClinical Solutions hosts ENGAGE 2026 with 250+ attendees exploring clinical data management solutions for FDA compliance and trial operations.
WCG’s Activation Intelligence Saves 20 Hours Per Study Activation
WCG's Activation Intelligence cuts study activation time by 20 hours per trial by reconciling conflicting information across protocols and...
GCCL and LabConnect Sign MOU for Cross-Regional Clinical Trial Support
GCCL and LabConnect sign MOU to streamline cross-regional clinical trial support across North America and Asia-Pacific laboratories.
AKIR001 radiopharmaceutical shows no dose-limiting toxicities in eight patients
AKIR001 radiopharmaceutical shows no dose-limiting toxicities in eight patients, with imaging confirming selective tumor targeting in first-in-human trial.
ArkBio Gets FDA Clearance for AK0406 Influenza Prevention Phase II Trial
ArkBio receives FDA clearance for AK0406, a drug-Fc conjugate designed to prevent influenza in adults during the upcoming U.S....