Regulatory

Ryoncil® commercial launch progress and upcoming product pipeline developments

The latest updates on the market rollout of Ryoncil® and insights into the company’s expanding pipeline of innovative therapies....

Bicycle Health achieves profitability and secures $16.5M to expand Virtual Opioid use Disorder Treatment

The funding will help scale access to telehealth-based opioid use disorder care across the U.S., improving patient reach and support....

Spectral AI completes Pediatric enrollment for U.S. Burn Pivotal Study in Emergency Departments

The study aims to advance AI-driven burn assessment technology for improved pediatric patient outcomes....

Zimmer Biomet to acquire Paragon 28 in Definitive Agreement

The acquisition aims to strengthen Zimmer Biomet’s position in the foot and ankle surgery market with Paragon 28’s specialized solutions....

FDA Approves LEQEMBI® IV Maintenance Dosing for Early Alzheimer’s Treatment

Lecanemab-irmb receives approval as a maintenance therapy, offering new hope for early-stage Alzheimer’s patients....

Strengthening India’s Healthcare Backbone: CDSCO’s Policy on Refurbished Medical Devices Paves Way for Domestic Innovation and Patient Safety

India Takes Steps to Address Healthcare Security by Backing CDSCO's Ban on Pre-Owned Medical Device Imports Amid 70% Import Dependency...

Illuccix® Secures European Approval

Breakthrough imaging agent advances prostate cancer diagnostics across Europe....

Santhera gains Positive NICE Guidance for AGAMREE® in treating Duchenne Muscular Dystrophy

Santhera has begun launch preparations for AGAMREE® in UK with first sales expected in this quarter ...

IHS achieves approval for global distribution of Insignis™ Infusion System

Rigorous audit paves the way for international availability of advanced infusion technology....

Indian Startup RNT Health Insights Secures Second FDA Breakthrough Designation for AI-Driven Esophageal Cancer Detection Tool

The Chandigarh-based health-tech startup advances gastroenterological diagnostics with its innovative AI-assisted technology, aimed at improving early detection and survival outcomes for esophageal cancer patients....