FDA Clears Combined Use of Restrata Matrix With Solventum V.A.C. Therapy
FDA clears combined use of Restrata Matrix with Solventum V.A.C. Therapy for integrated wound care, enabling simultaneous application of...
FDA Clears Haemonetics PerQseal Elite Vascular Closure System
FDA clears Haemonetics PerQseal Elite vascular closure system for large-bore arterial procedures, showing zero major complications in clinical trial.
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, leveraging the...
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 3 studies for sustained glaucoma...
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 inhibitors in NSCLC.
Orforglipron’s MACE Data Just Raised the Evidentiary Bar for Every Oral GLP-1 Program Behind It
Orforglipron's ACHIEVE-4 trial showed MACE-4 in 4.2% vs. 5.0% for insulin glargine, now every oral small-molecule GLP-1 program faces...
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, extending...
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 consumer devices used...
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 8.7-month median duration of...
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...