KORU Medical Systems Receives FDA 510(k) Clearance for Delivery of RYSTIGGO® (rozanolixizumab-noli), Expanding Label for FreedomEDGE® Infusion System
Repro Med Systems, Inc. (KRMD)
Company Research
Source: Business Wire
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 commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced that the Company received U.S. Food and Drug Administration (FDA) clearance for use of the KORU Medical FreedomEDGE® infusion system to deliver RYSTIGGO® (rozanolixizumab-noli), a therapy commercialized globally by UCB, Brussels, Belgium (www.ucb.com).The clearance for the FreedomEDGE® label includes indicated administration by a healthcare professional, increasing flexibility and access for patients living with generalized myasthenia (gMG). RYSTIGGO® is a novel biologic approved to treat adults with generalized myasthenia gravis (gMG), a rare, chronic autoimmune disorder that affects communication between nerves and muscles.¹ RYSTIGGO® is administered as a weekly infusion of 3mL-
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News
- KORU Medical Systems Receives FDA 510(k) Clearance for Delivery of RYSTIGGO® (rozanolixizumab-noli), Expanding Label for FreedomEDGE® Infusion System [Yahoo! Finance]Yahoo! Finance
- KORU Medical Systems (NASDAQ:KRMD) had its "buy" rating reaffirmed by analysts at Craig Hallum.MarketBeat
- KORU Medical Systems Reports Preliminary Q4 and Full Year 2025 Results; Achieves Record Revenue and Full Year Positive Operating Cash Flow [Yahoo! Finance]Yahoo! Finance
- KORU Medical Systems Reports Preliminary Q4 and Full Year 2025 Results; Achieves Record Revenue and Full Year Positive Operating Cash FlowBusiness Wire
- KORU Medical Systems (NASDAQ:KRMD) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=KRMD&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StreMarketBeat
KRMD
Earnings
- 11/12/25 - Beat
KRMD
Sec Filings
- 1/21/26 - Form SCHEDULE
- 1/15/26 - Form 4
- 1/15/26 - Form 3
- KRMD's page on the SEC website