Newsroom
April 28, 2026
Lasix® ONYU[1] Achieves CE Marking under EU Medical Device Regulation, Reaching a Critical Milestone Toward International Market Authorization; European Medicines Agency Confirms Eligibility for Centralized Procedure Review Based on Technical Innovation
- CE Marking confirms the device’s conformity with EU Medical Device Regulation (MDR 2017/745) General Safety and Performance Requirements (GSPRs)
- EMA centralized procedure acceptance on the basis of technical innovation expedites European process of Market Authorization.
BURLINGTON, Mass., April 28, 2026 /PRNewswire/ — SQ Innovation, developer of Lasix® ONYU, today announced two important regulatory milestones in its international expansion strategy: the receipt of a CE marking certificate for the Lasix ONYU device, and the acceptance of Lasix ONYU by the European Medicines Agency (EMA) for review under the centralized procedure on the basis of technical innovation.
April 21, 2026
Lasix® ONYU Now Available from Walmart Specialty Pharmacy for Home Delivery
Nationwide overnight delivery from Walmart improves access to novel at-home prescription treatment, with particular benefit for rural communities where transportation and distance are often barriers to timely treatment.
Burlington, MA – April 21, 2026 – SQ Innovation, developer of Lasix ONYU, today announced a collaboration with Walmart Specialty Pharmacy to expand nationwide access to this recently introduced subcutaneous furosemide treatment for patients with heart failure-related edema.
April 15, 2026
SQ Innovation and FIS Announce Strategic Supply Agreement for Furosemide API
Long-term partnership secures high-quality active pharmaceutical ingredient supply for Lasix® ONYU and future pipeline products
Burlington, MA, USA and Vicenza, Italy – April 15, 2026 – SQ Innovation, the developer of Lasix® ONYU (furosemide injection), and FIS Fabbrica Italiana Sintetici S.p.A. today announced a strategic supply agreement to secure the long-term availability of pharmaceutical-grade furosemide for SQ Innovation’s current and pipeline products across the United States, Europe, and global markets.
February 9, 2026
SQ Innovation’s Lasix® ONYU Now Available for Order Through Major U.S. Pharmaceutical Distributors
BURLINGTON, MASS., Feb. 9, 20206 /PRNewswire/ –SQ Innovation, Inc. today announced that following its FDA approval in October 2025, Lasix® ONYU (furosemide injection) is now available for ordering through Cardinal Health’s Specialty Pharmaceutical Distribution (SPD) and Cencora’s Specialty Distribution (Formerly AmerisouceBergen).
October 8, 2025
SQ Innovation Announces FDA Approval of Lasix® ONYU for Treatment of Edema in Heart Failure
SQ Innovation, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its drug-device combination Lasix® ONYU (furosemide injection) for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure
October 8, 2025
SQ Innovation AG Announces the Appointment of Two New Board Members and Successful Closing of Series B Financing to Support the U.S. Launch of Lasix® ONYU
SQ Innovation AG, a life-science company pioneering innovative solutions for the treatment of worsening heart failure, today announced the appointment of two distinguished executives to its Board of Directors: Mr. Marco van der Poel and Mr. Erik Massmann.
July 8, 2019
Ligand and SQ Innovation Enter into Exclusive Worldwide Captisol® License and Supply Agreements for High-Concentration Furosemide Formulation
SQ Innovation will use Ligand’s Captisol technology to achieve a smaller delivery volume for more cost-effective diuretic treatment in heart failure.