KORU Medical Systems (KRMD) FDA Approvals $4.17 +0.17 (+4.25%) As of 02:48 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider 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 AnnouncementProvided Update - July 2,2024Provided Update Drug: FreedomEdgeAnnounced Date: July 2, 2024Indication: Infusion system to deliver pegcetacoplan 20 mL solutionAnnouncementKORU Medical Systems, Inc announced that its state-of-the-art FreedomEdge® System has received regulatory clearance in Japan for the delivery of multiple drugs, including CSL Behring's Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical's Cuvitru SCIg, and Sobi's Aspaveli paroxysmal nocturnal hemoglobinuria (PNH).AI SummaryKORU Medical Systems, Inc. announced that its cutting-edge FreedomEdge® System has received regulatory clearance in Japan. This significant milestone allows the system to deliver multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg, and Sobi’s Aspaveli for paroxysmal nocturnal hemoglobinuria (PNH). The approval means that patients in Japan will have increased access to advanced treatments that are both precise and patient-friendly. The FreedomEdge® System is designed to provide reliable and efficient delivery of large volume subcutaneous therapies in both home and clinical settings. Its state-of-the-art design offers customizable treatment options tailored to meet the needs of patients and healthcare providers. This regulatory clearance in Japan marks an important step for KORU Medical Systems in broadening access to critical therapies, enhancing patient care outcomes, and strengthening its position in the international market.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. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Adagio Medical FDA EventsBioCardia FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsPrecision BioSciences FDA EventsHUTCHMED FDA EventsEli Lilly and Company FDA EventsTeleflex FDA EventsBioMarin Pharmaceutical FDA EventsDiaMedica Therapeutics FDA EventsDyne Therapeutics FDA EventsGuardant Health FDA EventsLigand Pharmaceuticals FDA EventsMadrigal Pharmaceuticals FDA EventsMetaVia FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Brainsway FDA Events Tactile Systems Technology FDA Events NeuroPace FDA Events Delcath Systems FDA Events ClearPoint Neuro FDA Events Sight Sciences FDA Events Profound Medical FDA Events Orchestra BioMed FDA Events Sanara MedTech FDA Events Apyx Medical FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:KRMD last updated on 12/31/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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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
Provided Update - July 2,2024Provided Update Drug: FreedomEdgeAnnounced Date: July 2, 2024Indication: Infusion system to deliver pegcetacoplan 20 mL solutionAnnouncementKORU Medical Systems, Inc announced that its state-of-the-art FreedomEdge® System has received regulatory clearance in Japan for the delivery of multiple drugs, including CSL Behring's Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical's Cuvitru SCIg, and Sobi's Aspaveli paroxysmal nocturnal hemoglobinuria (PNH).AI SummaryKORU Medical Systems, Inc. announced that its cutting-edge FreedomEdge® System has received regulatory clearance in Japan. This significant milestone allows the system to deliver multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg, and Sobi’s Aspaveli for paroxysmal nocturnal hemoglobinuria (PNH). The approval means that patients in Japan will have increased access to advanced treatments that are both precise and patient-friendly. The FreedomEdge® System is designed to provide reliable and efficient delivery of large volume subcutaneous therapies in both home and clinical settings. Its state-of-the-art design offers customizable treatment options tailored to meet the needs of patients and healthcare providers. This regulatory clearance in Japan marks an important step for KORU Medical Systems in broadening access to critical therapies, enhancing patient care outcomes, and strengthening its position in the international market.Read Announcement
