FDA Probes Elevidys Deaths, Stirring Regulatory and Market Uncertainty
FDA investigates Elevidys deaths, raising new safety and regulatory questions for gene therapies.
FDA
Digital Pathology Clearance Accelerates U.S. Market Entry
PathPresenter wins FDA clearance for digital pathology viewer, advancing primary diagnosis and LIS integration.
TISSIUM’s De Novo FDA Authorization Signals Industry Shift
FDA De Novo nod for TISSIUM’s COAPTIUM CONNECT: a new era in sutureless nerve repair.
Randox Gains FDA De Novo Clearance for Hemophilia CDx
Randox Laboratories has secured FDA de novo clearance for its ConcizuTrace ELISA companion diagnostic, designed to quantify plasma concentrations of Novo Nordisk’s recently approved hemophilia treatment Alhemo (concizumab-mtci). The regulatory milestone comes just weeks after Alhemo received FDA approval in December 2024 as a once-daily prophylactic injection for adults and pediatric patients 12 years and … Read more
Regulatory Roundup: Weekly Insights on Pharma and MedTech—Key Updates from Leading Agencies (December 30th to January 3rd)
Welcome to this week’s Regulatory Insights from Synopulse, featuring the latest updates from the FDA, EMA, and other global regulatory authorities. From groundbreaking drug approvals to critical recalls and new designations, we cover the most significant events driving the pharmaceutical sector. This comprehensive report offers a concise view of the regulatory milestones shaping the pharma, … Read more