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Regulatory News has published 25 Spotlight stories between 15 September 2026 and 24 September 2026, each sourced to the primary record — the Federal Register entry, the Official Journal notice, the guidance document or the regulator’s own release — and written and edited by Connor Griggs, the publication’s editor. Last updated 24 September 2026.

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25 milestones Updated September 24, 2026

Regulatory News Spotlight A woman leads a discussion at the head of a conference table while colleagues around her react and take notes EMACHMP opinion CHMP Recommends Zealand’s Zeydovio for Bowel Disease Europe's medicines committee backed glepaglutide, a twice-weekly GLP-2 analog, for adults with short bowel syndrome — less than two years after the same drug drew a rejection letter from FDA. Sep 24, 2026Read more Regulatory News Spotlight Two colleagues shake hands in a sunlit glass atrium, sealing a deal Financing$90M round HighLife Raises $90M for US Valve Trial, EU Growth The Paris company's largest round to date will fund a U.S. pivotal study of its transseptal mitral valve replacement and speed commercial expansion across Europe, four years after FDA cleared the trial to begin. Sep 24, 2026Read more Regulatory News Spotlight A smiling executive in a suit and yellow tie sits at a desk signing paperwork in a bright office FDA510(k) clearance TriSalus Wins FDA Clearance for TriNav Advance The Westminster, Colorado company's fifth Pressure-Enabled Drug Delivery catheter reaches small and distal vessels for the first time, without giving up the reflux protection that defines the platform, and begins a limited market release within weeks. Sep 24, 2026Read more Regulatory News Spotlight A confident executive in a gray suit stands in a bright glass-walled office corridor FDA510(k) clearance Traferox Lands FDA Clearance for X°Port Heart System The Toronto transplant-program spin-out won 510(k) clearance on 22 September 2026 for X°Port, a static preservation system that holds a donor heart at 10°C rather than the roughly 4°C of conventional ice storage — its second FDA clearance in three months, after a lung-perfusion system approved in July. Sep 23, 2026Read more Regulatory News Spotlight Colleagues applaud as one holds open a red folder in an office setting, marking an official milestone FDADe Novo authorization Powerful Medical Wins First FDA Nod for AI-ECG Tool The Bratislava-founded company’s Queen of Hearts model becomes the first AI-ECG software FDA has authorized specifically to flag acute heart attacks for urgent cardiologist review, a De Novo grant that arrives 18 months after a Breakthrough Device Designation and follows a European rollout the company says caught more than 120,000 heart attacks last year. Sep 23, 2026Read more Regulatory News Spotlight A gray-haired executive in a blazer smiles while reviewing bar and line charts on a printed report FinancingIPO Electra Therapeutics Prices $350M IPO for sHLH Drug The South San Francisco biotech upsized its Nasdaq debut to $350 million on 17 September 2026, earmarking roughly $220 million to carry ipsoprubart — an antibody already holding FDA Fast Track, FDA Breakthrough Therapy and EMA PRIME status — through a pivotal trial already dosing patients. Sep 22, 2026Read more Regulatory News Spotlight A researcher in a white lab coat and safety glasses uses a pipette over laboratory glassware FDADrug approval Curium Wins FDA Approval for First Radioligand Rival The Paris-based radiopharmaceutical maker won FDA approval for BEXLUTRY on 14 September 2026, the first radioligand therapy cleared through the 505(b)(2) pathway as an equivalent to Novartis’s Lutathera — three months after a Delaware court invalidated the patents that stood in its way. Sep 22, 2026Read more Regulatory News Spotlight Three researchers in white lab coats and safety goggles touch gloved fists together, smiling FinancingSeries A Dialybrid Raises €15M, Implants First Vascular Graft The Milan biomaterials company closed a €15 million Series A on 22 September 2026 and used the same announcement to disclose the first human implant of Silkothane, a silk-and-polyurethane arteriovenous graft designed to gradually integrate into hemodialysis patients rather than sit as inert plastic. Sep 22, 2026Read more Regulatory News Spotlight A researcher in a lab coat examines a sample closely, in profile, under laboratory lighting TGADevice authorization Koning Health Wins TGA Approval for Breast CT System The Norcross, Georgia company’s compression-free, cone-beam 3D scanner becomes authorized for commercial supply in Australia, extending a technology FDA first approved nearly a decade ago into a fifth market, with Brisbane Radiology named as the first buyer. Sep 21, 2026Read more Regulatory News Spotlight A businessperson in a blazer stands for a team portrait in a modern office setting MHLWDrug approval SK Biopharmaceuticals Completes Japan Epilepsy Approval Japan's Ministry of Health, Labour and Welfare approved cenobamate for partial-onset seizures on 16 September 2026, closing out a regulatory sweep across Korea, China and Japan for the Seongnam-based drugmaker and its partner Ono Pharmaceutical. Sep 21, 2026Read more Regulatory News Spotlight Two researchers in a laboratory examine a blue-tinted flask together Series EFinancing Circle Pharma Raises $92.5M Series E for Cancer Drug The South San Francisco biotech's oversubscribed round, led by The Column Group with Eli Lilly participating, funds CID-165, a first-in-class macrocycle designed to block a protein interaction that current CDK4/6 inhibitors don't touch, toward a first-quarter 2027 clinical start. Sep 21, 2026Read more Regulatory News Spotlight Three executives in business suits clasp hands together in a celebratory gesture FinancingSeries C Sling Nets $123M to Push Eye Drug Into Phase 3 The Ann Arbor biotech closed a $123 million Series C on 16 September 2026, led by Forbion, to carry linsitinib — an oral pill it says is the only IGF-1R inhibitor in late-stage development for thyroid eye disease — through its pivotal ORBIT trial and toward a filing that would challenge Amgen's infused Tepezza. Sep 20, 2026Read more Regulatory News Spotlight A researcher in a lab coat and glasses examines a flask of purple liquid held up to the light FDARMAT designation Cyllene Wins FDA RMAT Status for Bladder Gene Therapy The Paris company's EG110A, a one-time injection that silences the sensory nerves behind neurogenic detrusor overactivity after spinal cord injury, now holds Regenerative Medicine Advanced Therapy designation on the strength of an 88% drop in incontinence episodes — its third FDA designation in under a year. Sep 20, 2026Read more Regulatory News Spotlight A woman in a pinstripe blazer at a table with notes and a microphone during a press briefing FinancingSeries A RegCell Raises $66M for Nobel-Backed Treg Therapy The Emeryville, California company’s $44 million Series A and a second non-dilutive grant from Japan’s AMED will fund an FDA IND submission and a second autoimmune program for the cell therapy platform built on Shimon Sakaguchi’s Nobel-winning regulatory T-cell science. Sep 19, 2026Read more Regulatory News Spotlight An older man in glasses answers questions as microphones and a phone are held toward him FDA510(k) clearance Shoulder Innovations Clears FDA Hurdle for N-22 Implant The Grand Rapids, Michigan company’s titanium N-22 Humeral Head, cleared 10 September 2026 and launched immediately, gives surgeons a metal-hypersensitive option in anatomic shoulder replacement to match the reverse-arthroplasty implant it cleared in January. Sep 19, 2026Read more Regulatory News Spotlight A man at a desk with two monitors annotates a printed document with a pen EU MDRCE Mark FemPulse Earns CE Mark for Wearable Bladder Ring The Minnesota company’s self-inserted, silicone neuromodulation ring won EU MDR certification on 17 September 2026, offering the estimated one in five women worldwide with overactive bladder a non-surgical alternative to medication or an implant. Sep 19, 2026Read more Regulatory News Spotlight A close-up of a hand signing a contract document with a gold pen next to a laptop FinancingSeries A Matisse Raises €14M for Phase 2 Sepsis Drug Trial The Dutch biotech closed the round six months after FDA cleared isupartob sodium’s IND and granted it Fast Track designation, funding a trial of a first-in-class drug that neutralizes the histones sepsis releases into the bloodstream. Sep 18, 2026Read more Regulatory News Spotlight Three people in business attire speak into microphones held out by reporters in a conference room FDABreakthrough Device CorTec Lands Second FDA Breakthrough Nod for BCI The same fully implanted Brain Interchange hardware that is already in an FDA feasibility study for stroke rehabilitation has now earned a second Breakthrough Device Designation, this one for letting people with paralysis in all four limbs control a computer by thought. Sep 18, 2026Read more Regulatory News Spotlight A researcher in a lab coat gestures toward a whiteboard of chemical formulas while a colleague examines a sample under a microscope FDADrug approval Scholar Rock Wins FDA Nod for First SMA Muscle Drug ISEMBYLD (apitegromab-mstn) is designed to be added on top of an existing SMN2-targeted therapy rather than replace it, and in the pivotal SAPPHIRE trial it moved a 12-month motor-function score that placebo patients did not. Sep 18, 2026Read more Regulatory News Spotlight Pharming Group's glass-fronted global headquarters in Leiden, the Netherlands FDADrug approval Pharming Wins FDA Nod to Extend Joenja to Kids The Leiden, Netherlands company’s leniolisib now covers children ages 4 to 11 weighing at least 27 kilograms with Activated PI3K-Delta Syndrome, an ultra-rare primary immunodeficiency — the first FDA-approved APDS treatment for that age group, cleared six weeks ahead of its target review date. Sep 17, 2026Read more Regulatory News Spotlight A paramedic in blue gloves holds an LVOne test cassette in front of a yellow NHS ambulance CE markDevice authorization UpFront Diagnostics Earns CE Mark for Stroke Test The Cambridge, UK startup’s LVOne reads two blood biomarkers from a fingerstick sample to flag large-vessel-occlusion stroke before a patient reaches hospital, and is already piloting with London Ambulance Service crews across north London. Sep 17, 2026Read more Regulatory News Spotlight Illustration of the Emboliner embolic protection filter deployed across the aortic arch during TAVR FDA510(k) clearance Emboline Clears FDA Hurdle for TAVR Debris Filter The Santa Cruz, California company’s Emboliner protects the brain and the rest of the body during transcatheter aortic valve replacement, and beat the only other cleared device on technical success and debris capture in a 522-patient head-to-head trial. Sep 17, 2026Read more Regulatory News Spotlight A young woman wearing an iLet Bionic Pancreas pump clipped at her waist FDA510(k) clearance Beta Bionics Wins FDA Clearance for Mint Patch Pump The Irvine, California company becomes the second manufacturer with a cleared tubeless insulin patch pump in the United States, filed a 510(k) for its next-generation 3D Intelligence dosing algorithm the same day, and set a full U.S. launch for the first quarter of 2027. Sep 15, 2026Read more Regulatory News Spotlight Rendering of bacteriophages landing on the rippled blue surface of a bacterial cell FDABreakthrough designation Armata Wins Breakthrough Status for Phage Therapy AP-SA02 The Los Angeles bacteriophage developer now holds QIDP, Fast Track and Breakthrough Therapy designations for AP-SA02, an intravenous phage cocktail given alongside antibiotics for complicated Staphylococcus aureus bacteremia, on Phase 2 data showing 100% relapse-free response versus 75% on placebo. Sep 15, 2026Read more Regulatory News Spotlight Diagram of the JBS-003 approach with F-MISO PET scans of an oropharyngeal tumor FDABreakthrough designation Juniper Lands Breakthrough Status for Hypoxia PET Tracer The New Jersey company’s F-MISO imaging agent, licensed from Memorial Sloan Kettering, maps tumor hypoxia so that patients with HPV-positive oropharyngeal cancer whose tumors are not oxygen-starved can be treated with 30 Gray instead of 70. The designation is the first for a hypoxia tracer in the United States. Sep 15, 2026Read more