KORU Medical Systems (KRMD) FDA Approvals $3.40 -0.15 (-4.23%) As of 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock KORU Medical Systems' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by KORU Medical Systems (KRMD). Over the past two years, KORU Medical Systems has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as FreedomEdge. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. FreedomEdge FDA Regulatory Events FreedomEdge is a drug developed by KORU Medical Systems for the following indication: Infusion system to deliver pegcetacoplan 20 mL solution. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Provided Update - December 30,2025Provided Update Drug: FreedomEdgeAnnounced Date: December 30, 2025Indication: Infusion system to deliver pegcetacoplan 20 mL solutionAnnouncementKORU Medical Systems, Inc announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1AI SummaryKORU Medical Systems announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration seeking clearance to use its FreedomEDGE® infusion system to deliver PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf) subcutaneously for HER2-positive breast cancer. The filing is a key step in KORU’s plan to expand FreedomEDGE beyond immunoglobulin treatments into the oncology infusion center market. The company says subcutaneous delivery can speed drug administration, reduce patient chair time, and support a more efficient care model compared with intravenous infusions. Infusion centers still face nursing challenges such as complex workflows, long setup times, and physical discomfort for patients and staff. FreedomEDGE is designed to provide consistent, controlled large‑volume subcutaneous delivery while simplifying clinical workflows. KORU says the system could improve nursing satisfaction by reducing setup time and physical strain. The company anticipates entering the market after receiving 510(k) clearance.Read Announcement KORU Medical Systems FDA Events - Frequently Asked Questions Has KORU Medical Systems received FDA approval? As of now, KORU Medical Systems (KRMD) has not received any FDA approvals for its therapy in the last two years. What drugs has KORU Medical Systems submitted to the FDA? In the past two years, KORU Medical Systems (KRMD) has reported FDA regulatory activity for FreedomEdge. What is the most recent FDA event for KORU Medical Systems? The most recent FDA-related event for KORU Medical Systems occurred on December 30, 2025, involving FreedomEdge. The update was categorized as "Provided Update," with the company reporting: "KORU Medical Systems, Inc announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1" What conditions do KORU Medical Systems' current drugs treat? Currently, KORU Medical Systems has one therapy (FreedomEdge) targeting the following condition: Infusion system to deliver pegcetacoplan 20 mL solution. 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Provided Update - December 30,2025Provided Update Drug: FreedomEdgeAnnounced Date: December 30, 2025Indication: Infusion system to deliver pegcetacoplan 20 mL solutionAnnouncementKORU Medical Systems, Inc announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1AI SummaryKORU Medical Systems announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration seeking clearance to use its FreedomEDGE® infusion system to deliver PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf) subcutaneously for HER2-positive breast cancer. The filing is a key step in KORU’s plan to expand FreedomEDGE beyond immunoglobulin treatments into the oncology infusion center market. The company says subcutaneous delivery can speed drug administration, reduce patient chair time, and support a more efficient care model compared with intravenous infusions. Infusion centers still face nursing challenges such as complex workflows, long setup times, and physical discomfort for patients and staff. FreedomEDGE is designed to provide consistent, controlled large‑volume subcutaneous delivery while simplifying clinical workflows. KORU says the system could improve nursing satisfaction by reducing setup time and physical strain. The company anticipates entering the market after receiving 510(k) clearance.Read Announcement
