clinicaltrialvanguard

FDA Clears Haemonetics PerQseal Elite Vascular Closure System

FDA clears Haemonetics PerQseal Elite vascular closure system for large-bore arterial procedures, showing zero major ...
clinicaltrialvanguard

UP Oncolytics Gets $2.5M NIH Funding for Zika Virus Glioblastoma Therapy

UP Oncolytics secures $2.5M NIH funding to advance engineered Zika virus glioblastoma therapy toward first human trial, ...
clinicaltrialvanguard

SpyGlass Pharma’s Bimatoprost Pad-IOL Shows Four-Year Durability Data

SpyGlass Pharma's Bimatoprost Pad-IOL demonstrates four-year durability in first-in-human trial, supporting two ongoing Phase ...
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Mabwell’s 9MW2821 Shows 30% Response Rate in ADC-Pretreated TNBC

Mabwell's 9MW2821 demonstrated a 30% response rate in ADC-pretreated triple-negative breast cancer patients, with an ...
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Wearable Devices Face Accuracy Gaps in Clinical Trial Endpoints

Wearable devices show accuracy gaps in clinical trial endpoints, with sleep stage detection varying significantly across ...
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Icotrokinra’s NEJM Data Reveals the Quiet Shift in How UC Trials Get Designed and Approved

J&J's icotrokinra hit every UC endpoint in NEJM's Oct 2026 data, and the trial design choices behind that success are ...
clinicaltrialvanguardOpinion

The Dystrophin Standard: How a 1% Biomarker Signal Became a $967 Million Accelerated Approval Precedent

FDA granted four DMD antisense oligonucleotide accelerated approvals on ~1 percentage-point dystrophin increases. With $967M ...
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ArriVent’s Firmonertinib Phase 1b Data Published in Cancer Cell

ArriVent's firmonertinib Phase 1b data published in Cancer Cell, targeting EGFR PACC mutations resistant to standard ...
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The CHMP’s October Scorecard: Six Approvals, Five Expansions, and What the Patterns Reveal About EMA’s Evolving Evidence Bar

EMA's CHMP recommended 6 new medicines and 5 label expansions in its Oct 12-15 cycle. Here's what daraxonrasib's pancreatic ...
clinicaltrialvanguard

Fortrea Used Pre-Screening Logs to Fix Hypercholesterolemia Trial Enrollment

Fortrea rescued a Phase III hypercholesterolemia trial enrollment by using pre-screening logs and targeted site interventions ...
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IQVIA Selects Veeva Clinical Operations Applications as Enterprise Standard Across Its Studies

IQVIA has made Veeva CTMS, eTMF, Study Startup and Site Connect enterprise standards across its clinical development studies, ...
clinicaltrialvanguard

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 ...