Tovecimig Dosed in First-Line Biliary Tract Cancer Trial
Compass Therapeutics has initiated the first patient dosing in an Investigator Sponsored Trial (IST) at MD Anderson Cancer Center....
Elutia Launches Elupro™ Registry Study
Elutia Inc. launched a clinical study to gather real-world data on patient outcomes using EluPro, its FDA-cleared antibiotic-eluting bioenvelope...
How FDA’s Guidance on Decentralized Trials Applies to Community-based Research Execution and Compliance
In September 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance titled Conducting Clinical Trials with Decentralized...
Regeneron Eylea HD 8 mg Update: Biologics License Application
Regeneron Pharmaceuticals received a Complete Response Letter (CRL) from the FDA regarding its application to extend EYLEA HD’s dosing...
Sernova Secures $4M Loan for Clinical Development
Sernova Biotherapeutics secured a CAD$4 million term loan from Navigate Private Yield Fund LP III. The loan, which matures...
Non-Invasive Vagus Nerve Stimulation: Effective Concussion Treatment
ElectroCore, Inc. announced positive data from a study presented at the 2025 International Brain Injury Association World Congress, showing...
Namodenoson’s Compassionate Use For Pancreatic Cancer Sought By US Medical Centers
Can-Fite BioPharma announced that major U.S. medical centers are requesting FDA compassionate use approval for Namodenoson, its pancreatic cancer...
Alector Announces Phase 2 Trial Completion for Early Alzheimer’s Disease
Alector and GSK have completed enrollment in their Phase 2 PROGRESS-AD trial, evaluating AL101/GSK4527226 for early-stage Alzheimer’s diseaseAlzheimer’s disease....
uniQure Announces FDA Breakthrough Therapy Designation Granted to AMT-130
uniQure’s AMT-130 gene therapy for Huntington’s disease has received Breakthrough Therapy designation from the FDA, adding to its existing...
Nurix’s Novel IRAK4 Degrader, GS-6791/NX-0479, Gets FDA Clearance
Nurix Therapeutics announced FDA clearance of the Investigational New Drug (IND) application for GS-6791/NX-0479, an IRAK4 degrader. This allows...