• SQ Innovation's Lasix ONYU, a combination of furosemide and an on-body device, receives tentative FDA approval for treating fluid overload in congestive heart failure.
• The device, developed with Gerresheimer, allows precise, controlled drug administration and is designed for patient comfort and environmental sustainability.
• Lasix ONYU aims to reduce healthcare costs by enabling home treatment, potentially decreasing hospital stays for elderly patients with heart failure.
• Full FDA approval is expected after October 2025, following the expiration of a competitor's market exclusivity, with product availability anticipated by late 2025.