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Haypp Group Issues Statement on FDA’s Modified Risk Orders for Specific ZYN Products

WASHINGTON--(BUSINESS WIRE)--Haypp Group, parent company of Nicokick.com and Northerner.com, today issued the following statement in response to the U.S. Food and Drug Administration’s (FDA) June 30 announcement that it had issued modified risk orders for 20 specific ZYN nicotine pouch products following extensive scientific review.Under the orders, these nicotine pouch products, which have been authorized for sale in the U.S. since January 2025, may now be marketed with the following modified r...
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LEO Pharma Announces Key Results of Phase 2 TRAPEDS-1 Trial Evaluating Pharmacokinetics and Safety of Tralokinumab in Children With Moderate-to-Severe Atopic Dermatitis

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma announces key results of Phase 2 TRAPEDS-1 trial evaluating pharmacokinetics and safety of tralokinumab...
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Arialys Therapeutics Announces U.S. FDA Fast Track Designation for ART5803, the First Precision Therapeutic Candidate in Development for the Treatment of Anti-NMDA Receptor Encephalitis

LA JOLLA, Calif.--(BUSINESS WIRE)--Arialys Announces U.S. FDA Fast Track Designation for ART5803, the First Precision Therapeutic Candidate in Development for the Treatment of ANRE...
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NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer

FORT MYERS, Fla.--(BUSINESS WIRE)--NeoGenomics launched PTEN IHC CDx, the first IHC companion diagnostic test approved by the U.S. FDA for patients with prostate adenocarcinoma....
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iHealthScreen Receives U.S. FDA 510(k) Clearance (K253704) for iPredict-DR, an AI-Powered Software for Automated Diabetic Retinopathy Screening

RICHMOND HILL, N.Y.--(BUSINESS WIRE)--iHealthScreen, Inc., a healthcare AI company developing Software as a Medical Device (SaMD) for retinal and cardiovascular disease screening and preventive healthcare, today announced FDA 510(k) clearance (K253704) for iPredict-DR™, its AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes not previously diagnosed with the condition. Diabetic retinopathy is a leading cause of preventable blindness...
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Riassunto: Leo Cancer Care raccoglie 65 milioni di dollari in un round di finanziamento di serie D per ampliare la sua piattaforma verticale di terapia oncologica integrata

MIDDLETON, Wis. e LONDRA--(BUSINESS WIRE)--Leo Cancer Care, l'azienda specializzata in tecnologia medica impegnata a reinventare le modalità di diagnosi per immagini e di trattamento dei pazienti progettando sistemi basati sulla naturale posizione eretta del corpo, oggi ha annunciato la chiusura di un finanziamento di serie D da 65 milioni di dollari, sottoscritto in eccesso. Il round è stato condotto da Yu Galaxy, della Silicon Valley, e accoglie nuovi investitori, tra cui Eventide Asset Manag...
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Resumen: Leo Cancer Care recauda USD 65 millones en una ronda de financiación Serie D para ampliar su plataforma integrada de atención oncológica en posición vertical

MIDDLETON, Wisconsin y LONDRES--(BUSINESS WIRE)--Leo Cancer Care, la empresa de tecnología médica que trabaja para reinventar la forma en que se obtienen imágenes y se trata a los pacientes a partir del diseño de sistemas basados en la posición vertical natural del cuerpo, anunció hoy el cierre de una ronda de financiación Serie D sobresuscrita por USD 65 millones. La ronda fue liderada por Yu Galaxy, de Silicon Valley, e incorpora nuevos inversores, entre ellos Eventide Asset Management, ademá...
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Samenvatting: Leo Cancer Care haalt een Serie D-financiering van $65 miljoen op om zijn geïntegreerde platform voor rechtopstaande kankerzorg op schaal te brengen

MIDDLETON, Wis. & LONDEN--(BUSINESS WIRE)--Leo Cancer Care, het bedrijf gespecialiseerd in medische technologie dat zich inzet om de manier waarop aandoeningen van patiënten in beeld worden gebracht en behandeld volledig te herwerken door systemen rond de natuurlijke rechtopstaande houding van het lichaam te ontwerpen, maakte vandaag de afronding bekend van een overtekende Serie D-financiering van $65 miljoen. De financieringsronde werd geleid door Silicon Valley’s Yu Galaxy en verwelkomt nieuw...
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Leo Cancer Care lève 65 millions de dollars lors d'un tour de table de série D destiné à développer sa plateforme intégrée de soins du cancer en position verticale

MIDDLETON, Wisconsin et LONDRES--(BUSINESS WIRE)--Leo Cancer Care, société de technologies médicales qui réinvente la façon dont les patients sont imagés et traités en concevant des systèmes adaptés à la position verticale naturelle du corps, a annoncé aujourd'hui la clôture d'un tout de table de série D sursouscrit de 65 millions de dollars . Ce tour de table a été mené par Yu Galaxy, société de la Silicon Valley, et intègre de nouveaux investisseurs comme Eventide Asset Management, tout en co...
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Leo Cancer Care sammelt in einer Serie-D-Finanzierungsrunde $65 Millionen ein, um seine integrierte Plattform für die onkologische Versorgung „Upright“ auszubauen

MIDDLETON, Wis. & LONDON--(BUSINESS WIRE)--Leo Cancer Care ist das Medizintechnikunternehmen, das daran arbeitet, Bildgebungsverfahren und Behandlungsmethoden für Patienten in aufrechter, natürlicher Position zu entwickeln. Es gab heute den Abschluss einer überzeichneten D-Finanzierungsrunde in Höhe von $65-Millionen bekannt. Die Runde wurde angeführt von Yu Galaxy und heißt neue Investoren willkommen wie Eventide Asset Management . Auch bestehende Investoren beteiligten sich erneut. Führende K...