https://pharmadevicenews.com/forlong-biotechnology-doses-first-patient-in-australian-phase-1-trial-of-subcutaneous-fl115/ PharmaDeviceNews en 2026-10-29T03:40:42+00:00 Forlong Biotechnology doses first patient in Australian Phase 1 trial of subcutaneous FL115 American Society of Clinical Oncology, Australia, China, Dong Wei, Fbody, FL115, FL116, Forlong Biotechnology, JOINN Biologics, Therapeutic Goods Administration, United States https://pharmadevicenews.com/wp-content/uploads/2026/06/Ranok-Therapeutics-enters-the-KRAS-G12D-spotlight-with-early-clinical-activity-data-e1780405932498.webp https://pharmadevicenews.com/nateras-signatera-genome-separates-bladder-cancer-patients-into-91-81-and-55-survival-groups-but-can-mrd-guide-treatment/ PharmaDeviceNews en 2026-10-29T03:37:06+00:00 Natera’s Signatera Genome separates bladder cancer patients into 91%, 81% and 55% survival groups, but can MRD guide treatment? AstraZeneca, Clarity, ESMO, HER2-CR, IMvigor011, KEYNOTE-B21, MDT-Bridge, Minetta Liu, Natera Inc., Roche, Signatera CDx, Signatera Genome, Thomas Powles, VOLGA https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-Cancer-generic.webp https://pharmadevicenews.com/neurogene-reports-rapid-mecp2-expression-and-new-gene-regulation-data-for-ngn-401-in-rett-syndrome/ PharmaDeviceNews en 2026-10-29T03:32:50+00:00 Neurogene reports rapid MECP2 expression and new gene regulation data for NGN-401 in Rett syndrome Embolden, ESGCT, EXACT, Hamburg, MECP2, Neurogene Inc., NGN-401, Rachel McMinn, United States Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/08/Doctor-consultation-e1787168079387.webp https://pharmadevicenews.com/dyno-therapeutics-reports-152-fold-brain-transduction-improvement-and-new-immune-evasive-aav-capsid-data-at-esgct-2026/ PharmaDeviceNews en 2026-10-28T04:38:07+00:00 Dyno Therapeutics reports 152-fold brain transduction improvement and new immune-evasive AAV capsid data at ESGCT 2026 AAV9, Adrian Veres, Astellas Pharma, Daniela Pignatta, Dyno Therapeutics, Dyno-9zh, ESGCT, European Society of Gene and Cell Therapy, Hamburg, Mugdha Deshpande, MyoAAV-4E, NVIDIA, Roche, Sarah Hilton https://pharmadevicenews.com/wp-content/uploads/2026/09/ChatGPT-Image-Sep-25-2026-10_49_09-AM-e1790313593669.webp https://pharmadevicenews.com/rumi-therapeutics-signs-option-agreement-for-ind-ready-rtx-7340-pde2-inhibitor-in-fragile-x-syndrome/ PharmaDeviceNews en 2026-10-28T04:33:20+00:00 Rumi Therapeutics signs option agreement for IND-ready RTX-7340 PDE2 inhibitor in Fragile X syndrome Craig Erickson, ENT-7340, Enthorin Therapeutics, Fragile X syndrome, Ignacio Muñoz-Sanjuán, J. Guy Breitenbucher, RTX-7340, Rumi Scientific, Rumi Scientific Holdings, Rumi Therapeutics https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-Clinical-Trials.webp https://pharmadevicenews.com/powerful-medical-secures-cpt-code-1139t-for-queen-of-hearts-ai-ecg-after-fda-authorisation/ PharmaDeviceNews en 2026-10-28T04:30:20+00:00 Powerful Medical secures CPT code 1139T for Queen of Hearts AI ECG after FDA authorisation American Medical Association, Felix Bauer, PMcardio, Powerful Medical, Queen of Hearts, Robert Herman, United States, United States Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/07/Elucid-AI-PREDICT-study-begins-testing-lesion-level-heart-attack-risk-with-CCTA-e1783862389127.webp https://pharmadevicenews.com/kivo-health-raises-10m-series-a-led-by-allumia-ventures-to-expand-ai-powered-care-for-chronic-lung-disease/ PharmaDeviceNews en 2026-10-28T03:58:58+00:00 Kivo Health raises $10m Series A led by Allumia Ventures to expand AI-powered care for chronic lung disease Allumia Ventures, Corewell Health Ventures, Dan Galles, Heuristic Capital, Kivo Health, MassMutual Ventures, Stanford University, University of California Los Angeles, Victor Sadauskas, Y Combinator https://pharmadevicenews.com/wp-content/uploads/2026/07/CyPath-Lung-sales-rise-as-bioAffinity-Technologies-builds-specialty-specific-workflows-e1785229960616.webp https://pharmadevicenews.com/alterome-therapeutics-schedules-first-phase-1-clinical-data-presentation-for-pan-kras-inhibitor-alta3263/ PharmaDeviceNews en 2026-10-28T03:55:10+00:00 Alterome Therapeutics schedules first Phase 1 clinical data presentation for pan-KRAS inhibitor ALTA3263 ALTA3263, Alterome Therapeutics, American Association for Cancer Research, cetuximab, David S. Hong, EORTC, KRAS, MD Anderson Cancer Center, National Cancer Institute https://pharmadevicenews.com/wp-content/uploads/2026/05/Phanes-Therapeutics-spevatamig-posts-updated-Phase-2-data-in-first-line-metastatic-PDAC-e1780037386443.webp https://pharmadevicenews.com/arrowhead-pharmaceuticals-secures-nhs-funding-recommendation-for-redemplo-in-familial-chylomicronaemia-syndrome/ PharmaDeviceNews en 2026-10-28T03:51:05+00:00 Arrowhead Pharmaceuticals secures NHS funding recommendation for REDEMPLO in familial chylomicronaemia syndrome Action FCS, Arrowhead Pharmaceuticals, England, Imperial College London, MHRA, NICE, PALISADE, plozasiran, REDEMPLO, Wales https://pharmadevicenews.com/wp-content/uploads/2026/07/Arrowhead-Pharmaceuticals-stock-jumps-after-positive-Phase-3-plozasiran-trial-results-e1784779870509.webp https://pharmadevicenews.com/afimetoran-phase-2-trial-delivers-significant-lupus-improvement-as-beeline-medicines-eyes-pivotal-studies/ PharmaDeviceNews en 2026-10-27T23:51:45+00:00 Afimetoran Phase 2 trial delivers significant lupus improvement as Beeline Medicines eyes pivotal studies Afimetoran, American College of Rheumatology, Beeline Medicines, Bristol Myers Squibb, U.S. Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/10/Autoimmune-disease-research-e1793144740150.webp https://pharmadevicenews.com/tafenoquine-combinations-show-promising-parasite-clearance-in-immunocompromised-patients-with-babesiosis/ PharmaDeviceNews en 2026-10-27T23:40:59+00:00 Tafenoquine combinations show promising parasite clearance in immunocompromised patients with babesiosis 60 Degrees Pharmaceuticals, ARAKODA, Babesia microti, Babesiosis, Brown University, Mayo Clinic, tafenoquine, Tufts Medical Center, U.S. Food and Drug Administration, Yale School of Public Health https://pharmadevicenews.com/wp-content/uploads/2026/10/Babesiosis-research-e1793144419202.webp https://pharmadevicenews.com/reyobiq-brain-cancer-trial-cerenome-advances-targeted-radiotherapy-ahead-of-phase-2-plans/ PharmaDeviceNews en 2026-10-27T21:57:27+00:00 REYOBIQ brain cancer trial: Cerenome advances targeted radiotherapy ahead of Phase 2 plans Cerenome, ReSPECT-LMM, REYOBIQ, Society for Neuro-Oncology https://pharmadevicenews.com/wp-content/uploads/2026/10/Brain-cancer-research-e1793137820879.webp https://pharmadevicenews.com/sync-t-prostate-cancer-treatment-shows-encouraging-long-term-survival-as-legion-100-trial-expands/ PharmaDeviceNews en 2026-10-27T21:45:13+00:00 SYNC-T prostate cancer treatment shows encouraging long-term survival as LEGION-100 trial expands Carlos Vargas, Eamonn Hobbs, European Society for Medical Oncology, LEGION-100, SV-102, SYNC-T Therapy, Syncromune https://pharmadevicenews.com/wp-content/uploads/2026/10/Prostate-cancer-research-e1793137215571.webp https://pharmadevicenews.com/could-ati-052-offer-a-new-approach-to-asthma-and-eczema-phase-1b-findings-support-further-testing/ PharmaDeviceNews en 2026-10-27T21:22:51+00:00 Could ATI-052 offer a new approach to asthma and eczema? Phase 1b findings support further testing Aclaris Therapeutics, ATI-052, Icahn School of Medicine at Mount Sinai, U.S. Food and Drug Administration, University of Leicester https://pharmadevicenews.com/wp-content/uploads/2026/10/Asthma-and-atopic-dermatitis-research-e1793136075746.webp https://pharmadevicenews.com/tremont-ai-partners-with-astrazeneca-to-develop-ai-models-for-preclinical-drug-safety-assessment/ PharmaDeviceNews en 2026-10-27T15:43:32+00:00 Tremont AI partners with AstraZeneca to develop AI models for preclinical drug safety assessment AstraZeneca PLC, Faisal Mahmood, Luca Weishaupt, Mass General Brigham, ToxScribe, TRACE, Tremont AI, Tremont Studio https://pharmadevicenews.com/wp-content/uploads/2025/12/pharmadevicenews-1.png https://pharmadevicenews.com/array-skin-therapy-opens-first-houston-clinic-to-expand-narrowband-uvb-treatment-access/ PharmaDeviceNews en 2026-10-27T15:40:30+00:00 Array Skin Therapy opens first Houston clinic to expand narrowband UVB treatment access Array Skin Therapy, Houston, Katy, LTA Wellness PLLC, Shir'mel McCullough, Susan Nguy, Texas https://pharmadevicenews.com/wp-content/uploads/2026/10/Skin-exam-e1791399327903.webp https://pharmadevicenews.com/alpheus-medical-reports-early-ldh-biomarker-findings-from-15-patient-glioblastoma-study/ PharmaDeviceNews en 2026-10-27T15:36:36+00:00 Alpheus Medical reports early LDH biomarker findings from 15-patient glioblastoma study Alpheus Medical, ESMO 2026, European Society for Medical Oncology, PoMA, Vijay Agarwal https://pharmadevicenews.com/wp-content/uploads/2026/07/Laminar-Pharma-closes-active-monitoring-phase-of-144-patient-LAM561-clinical-trial-e1784889343718.webp https://pharmadevicenews.com/orphan-therapeutics-accelerator-licenses-otxl-101-gene-therapy-to-revive-development-for-rare-paediatric-disease/ PharmaDeviceNews en 2026-10-27T15:13:42+00:00 Orphan Therapeutics Accelerator licenses OTXL-101 gene therapy to revive development for rare paediatric disease American Society of Gene & Cell Therapy, Children's Medical Research Institute, Craig Martin, Great Ormond Street Hospital, HORACE, Ian Alexander, Orphan Therapeutics Accelerator, OTXL-101, Paul Gissen, UCL Ventures, University College London https://pharmadevicenews.com/wp-content/uploads/2025/12/pharmadevicenews-1.png https://pharmadevicenews.com/abbvie-submits-fda-application-for-etentamig-after-phase-3-cervino-success-in-multiple-myeloma/ PharmaDeviceNews en 2026-10-27T15:07:54+00:00 AbbVie submits FDA application for etentamig after Phase 3 CERVINO success in multiple myeloma ABBV-383, AbbVie Inc., CERVINO, etentamig, International Myeloma Society, TECVAYLI, United States Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/09/Myeloma-treatment-setting-e1790350891203.webp https://pharmadevicenews.com/vincora-secures-fda-approval-for-nexus-transcatheter-chordal-repair-feasibility-study-in-the-us/ PharmaDeviceNews en 2026-10-27T15:04:29+00:00 Vincora secures FDA approval for NeXuS transcatheter chordal repair feasibility study in the US Azeem Latib, NeoChord Inc., Nexus, Todd Berg, United States Food and Drug Administration, Vincora https://pharmadevicenews.com/wp-content/uploads/2026/09/ChatGPT-Image-Sep-17-2026-11_17_57-AM-e1789624111280.webp https://pharmadevicenews.com/omabit-raises-2m-to-connect-fragmented-clinical-evidence-but-can-ai-improve-drug-development-decisions/ PharmaDeviceNews en 2026-10-27T12:20:29+00:00 Omabit raises $2m to connect fragmented clinical evidence, but can AI improve drug development decisions? Bright Ventures, Elena Cassidy, Lenore Champagne Beirne, Michael Snyder, Omabit, Stanford StartX, Stanford University https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-Generic-Image.webp https://pharmadevicenews.com/orbis-names-a-new-ceo-after-its-1-4bn-billion-novo-nordisk-deal-but-can-ai-designed-macrocycles-replace-injections/ PharmaDeviceNews en 2026-10-27T12:15:22+00:00 Orbis names a new CEO after its $1.4bn billion Novo Nordisk deal, but can AI-designed macrocycles replace injections? Be Biopharma, bluebird bio, Joanne Smith-Farrell, Lilly Ventures, Mikael Dolsten, Morten Graugaard, NEA, nGen, Novo Holdings, Novo Nordisk, Orbis Medicines https://pharmadevicenews.com/wp-content/uploads/2025/12/pharmadevicenews-1.png https://pharmadevicenews.com/stevanato-group-and-aptar-pharma-partner-to-accelerate-prefilled-syringe-system-selection-for-biologics/ PharmaDeviceNews en 2026-10-27T12:09:30+00:00 Stevanato Group and Aptar Pharma partner to accelerate prefilled syringe system selection for biologics Alba, Aptar Pharma, AptarGroup, EZ-fill, Nexa, PremiumCoat, Stevanato Group, United States Pharmacopeia, USP 382 https://pharmadevicenews.com/wp-content/uploads/2026/10/Stevanato-and-Aptar-combine-glass-syringes-and-elastomer-components-for-biologics-scaled-e1793102929677.webp https://pharmadevicenews.com/can-avanzanite-accelerate-nhs-access-to-rare-disease-medicines-in-the-uk/ PharmaDeviceNews en 2026-10-27T12:03:23+00:00 Can Avanzanite accelerate NHS access to rare disease medicines in the UK? Adam Plich, Agios Pharmaceuticals, Amicus Therapeutics, Avanzanite Bioscience, Chiesi, MHRA, MVM Partners, NHS, NICE, PYRUKYND, Sarah O'Connell https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-tablets-generic-e1788149113473.webp https://pharmadevicenews.com/enhertu-cut-breast-cancer-recurrence-risk-by-53-against-t-dm1-but-will-lung-toxicity-affect-its-use/ PharmaDeviceNews en 2026-10-27T11:04:05+00:00 Enhertu cut breast cancer recurrence risk by 53% against T-DM1, but will lung toxicity affect its use? AstraZeneca, Daiichi Sankyo, DESTINY-Breast05, Enhertu, European Commission, European Medicines Agency, European Society for Medical Oncology, KADCYLA, KATHERINE, New England Journal of Medicine, trastuzumab deruxtecan, trastuzumab emtansine https://pharmadevicenews.com/wp-content/uploads/2026/06/Ibrance-gains-FDA-approval-across-HER2-status-extending-Pfizers-breast-cancer-franchise-e1782660591861.webp