Benzinga.com

Earlier, FDA Approved Marketing of RMS Subcutaneous Needle Sets

announced today that it has received approval from the Food and Drug Administration (FDA) to begin U.S. marketing of its new Subcutaneous Needle Sets which the company is promoting as the HIgh Flo™ ...
Business Wire

Innovative Health Sciences Receives FDA Clearance for Insignis™ Subcutaneous Needle Sets

CHESTER, N.Y.--(BUSINESS WIRE)--Innovative Health Sciences, LLC (“IHS” or the “Company”) management announced today that IHS has received FDA clearance for its Insignis™ Subcutaneous Needle Sets. This ...
Yahoo Finance

KORU Medical Systems Announces Development Agreement for Innovation in Subcutaneous Immunoglobulin Infusion Systems

MAHWAH, N.J., November 04, 2025--(BUSINESS WIRE)--KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, ...
Business Wire

KORU Medical Systems, Inc. Receives FDA 510(k) Clearance for FREEDOM60® Infusion System With Hizentra® 50 ML Prefilled Syringes

MAHWAH, N.J.--(BUSINESS WIRE)--KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and ...
Nasdaq

Supernus Pharmaceuticals Announces FDA Approval of ONAPGO, the First Subcutaneous Apomorphine Infusion Device for Parkinson's Disease in the U.S.

ONAPGO, a subcutaneous infusion device, treats motor fluctuations in advanced Parkinson's disease and launches in the U.S. in 2025. Supernus Pharmaceuticals has announced the FDA approval of ONAPGO, ...
Stockhouse

Takeda Announces Approval of HYQVIA® 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia

Takeda (TSE:4502/NYSE:TAK) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant ...
Monthly Prescribing Reference

Remunity Pump for Remodulin Now Available

Remunity Pump is intended for continuous subcutaneous delivery of Remodulin in prefilled cassettes for the treatment of PAH in adults aged ≥22 years. Remunity ® Pump for Remodulin ® (treprostinil; ...