https://pharmadevicenews.com/vivacta-and-grit-bio-advance-cd19-targeting-car-t-without-external-cell-manufacturing/ PharmaDeviceNews en 2026-10-18T16:58:48+00:00 Vivacta and Grit Bio advance CD19-targeting CAR-T without external cell manufacturing American Society of Gene and Cell Therapy, Autoimmune Hemolytic Anemia, B-cell depletion, CD19, cell therapy, CLAMP Technology, FDA, Grit Biotherapeutics, GT801, in vivo CAR-T, lipid nanoparticles, Messenger RNA, orphan drug designation, Vivacta Bio, Yarong Liu https://pharmadevicenews.com/wp-content/uploads/2026/06/Johnson-Johnson-strengthens-nipocalimabs-FDA-case-with-rapid-hemoglobin-improvement-e1781938581377.webp https://pharmadevicenews.com/can-a-pulse-oximeter-detect-atrial-fibrillation-before-symptoms-appear-masimo-reports-97-sensitivity/ PharmaDeviceNews en 2026-10-18T16:55:11+00:00 Can a pulse oximeter detect atrial fibrillation before symptoms appear? Masimo reports 97% sensitivity artificial intelligence, atrial fibrillation, Danaher, Electrocardiography, FDA, Hospital Patient Safety, Masimo, Masimo SET, Opioid-Induced Respiratory Depression, patient monitoring, photoplethysmography, Pulse Oximetry, Radius VSM, smartSET https://pharmadevicenews.com/wp-content/uploads/2026/10/Masimo-smartSET-receives-FDA-clearance-for-atrial-fibrillation-detection-e1792342473285.webp https://pharmadevicenews.com/ionis-tryngolza-wins-eu-recommendation-after-85-reduction-in-pancreatitis-events/ PharmaDeviceNews en 2026-10-18T16:50:29+00:00 Ionis TRYNGOLZA wins EU recommendation after 85% reduction in pancreatitis events acute pancreatitis, apolipoprotein C-III, CHMP, CORE, CORE2, European Commission, European Medicines Agency, familial chylomicronemia syndrome, Ionis Pharmaceuticals, olezarsen, severe hypertriglyceridemia, Sobi, TIMI Study Group, Tryngolza https://pharmadevicenews.com/wp-content/uploads/2026/06/Ionis-Pharmaceuticals-wins-FDA-approval-for-Tryngolza-in-severe-hypertriglyceridemia-e1782660918624.webp https://pharmadevicenews.com/estuary-launches-with-103m-to-develop-gene-therapies-for-polycystic-kidney-disease/ PharmaDeviceNews en 2026-10-18T05:59:09+00:00 Estuary launches with $103m to develop gene therapies for polycystic kidney disease 4BIO Capital, autosomal dominant polycystic kidney disease, Biogen New Ventures, Deep Track Capital, EST-101, EST-201, Estuary Biotherapeutics, gene therapy, GV, Michael Caplan, National Kidney Foundation Innovation Fund, PKD1, PKD2, RA Capital Management, Stefan Somlo, UPMC Enterprises, Wayne Sackett, Yale School of Medicine https://pharmadevicenews.com/wp-content/uploads/2026/02/Arcus-Biosciences-casdatifan-data-test-whether-next-generation-HIF-2α-inhibition-can-outperform-late-line-kidney-cancer-expectations-e1771916981796.webp https://pharmadevicenews.com/omeros-faces-second-european-rejection-for-yartemlea-despite-us-approval/ PharmaDeviceNews en 2026-10-18T05:55:32+00:00 Omeros faces second European rejection for YARTEMLEA despite US approval CHMP, complement inhibition, European Medicines Agency, FDA, Gregory Demopulos, Hematopoietic Stem Cell Transplantation, MASP-2, narsoplimab, Omeros Corporation, OMS1029, Transplant-Associated Thrombotic Microangiopathy, YARTEMLEA https://pharmadevicenews.com/wp-content/uploads/2026/01/transplant‑associated-thrombotic-microangiopathy.webp https://pharmadevicenews.com/fda-approves-genentechs-enspryng-as-first-at-home-treatment-for-thyroid-eye-disease/ PharmaDeviceNews en 2026-10-18T05:40:08+00:00 FDA approves Genentech’s ENSPRYNG as first at-home treatment for thyroid eye disease autoimmune diseases, Chugai Pharmaceutical, Enspryng, FDA, Genentech, Graves Ophthalmopathy, Interleukin-6 Receptor, ophthalmology, Roche, SatraGO-1, SatraGO-2, satralizumab, Tepezza, thyroid eye disease https://pharmadevicenews.com/wp-content/uploads/2026/06/Viridian-launches-Lumvoa-after-FDA-approval-opening-first-direct-challenge-to-Tepezza-e1782532224938.webp https://pharmadevicenews.com/organon-reports-3-9-six-year-pregnancy-rate-with-hormone-free-miudella-iud/ PharmaDeviceNews en 2026-10-18T04:25:31+00:00 Organon reports 3.9% six-year pregnancy rate with hormone-free MIUDELLA IUD Copper IUD, FDA, hormone-free contraception, Juan Camilo Arjona Ferreira, Kelly Culwell, long-acting reversible contraception, MIUDELLA, nitinol, Organon, Paragard, REMS, Sebela Women's Health, Society of Family Planning, VeraCept, women’s health https://pharmadevicenews.com/wp-content/uploads/2025/12/pharmadevicenews-1.png https://pharmadevicenews.com/can-virions-t-cell-immunotherapy-help-achieve-a-functional-hepatitis-b-cure/ PharmaDeviceNews en 2026-10-17T16:30:19+00:00 Can Virion’s T-cell immunotherapy help achieve a functional hepatitis B cure? AASLD 2026, Andrew Luber, chronic hepatitis B, Edward Gane, elebsiran, Grace Lai-Hung Wong, HBV functional cure, Hepatitis B Surface Antigen, Nucleoside Analogues, T-Cell Immunotherapy, The Lancet Microbe, The Liver Meeting, Tobevibart, Virion Therapeutics, VRON-0200 https://pharmadevicenews.com/wp-content/uploads/2025/12/chronic-hepatitis-B-infection.webp https://pharmadevicenews.com/palleon-to-present-hlx79-and-rituximab-combination-data-at-acr-convergence-2026/ PharmaDeviceNews en 2026-10-17T16:26:54+00:00 Palleon to present HLX79 and rituximab combination data at ACR Convergence 2026 ACR Convergence 2026, ASN Kidney Week, autoimmune kidney disease, Carolyn Bertozzi, E-602, Glycan Editing, HANLIKANG, HLX01, HLX79, Jim Broderick, Membranous Nephropathy, Palleon Pharmaceuticals, rituximab, Shanghai Henlius Biotech, Sialidase https://pharmadevicenews.com/wp-content/uploads/2026/09/Nephropathy-research-e1790188192921.webp https://pharmadevicenews.com/chipscreen-secures-china-trial-approval-for-pd-l1-targeted-epigenetic-antibody-conjugate/ PharmaDeviceNews en 2026-10-17T08:09:02+00:00 Chipscreen secures China trial approval for PD-L1-targeted epigenetic antibody conjugate advanced solid tumors, AI-ChemGen, Antibody Conjugates, Chidamide, China, Chipscreen Biosciences, Chipscreen Newway Biosciences, Epidaza, Epigenetic Immunotherapy, histone deacetylase inhibitors, immunotherapy resistance, NMPA, NW001, PD-L1 https://pharmadevicenews.com/wp-content/uploads/2026/01/antibody-targeted-therapy-in-lymphoma-treatment.webp https://pharmadevicenews.com/cofactors-oncoprism-predicts-71-immunotherapy-response-in-lung-cancer-subgroup/ PharmaDeviceNews en 2026-10-17T08:04:20+00:00 Cofactor’s OncoPrism predicts 71% immunotherapy response in lung cancer subgroup Cofactor Genomics, Gene Expression Classifiers, Genentech, Howard Bailey, immune checkpoint inhibitors, Jarret Glasscock, Kevin Flanagan, non-small cell lung cancer, OAK Trial, OncoPrism-HNSCC, OncoPrism-NSCLC, PD-L1, precision oncology, PREDAPT, RNA Sequencing https://pharmadevicenews.com/wp-content/uploads/2026/08/Lung-cancer-study-e1787082418957.webp https://pharmadevicenews.com/immunitybio-reports-84-three-year-bladder-preservation-among-anktiva-responders/ PharmaDeviceNews en 2026-10-17T07:59:30+00:00 ImmunityBio reports 84% three-year bladder preservation among ANKTIVA responders Altor BioScience, ANKTIVA, Bacillus Calmette-Guérin, carcinoma in situ, cystectomy, FDA, ImmunityBio, Journal of Urology, nogapendekin alfa inbakicept, non-muscle-invasive bladder cancer, Patrick Soon-Shiong, QUILT-3.032, Richard Adcock https://pharmadevicenews.com/wp-content/uploads/2026/07/ImmunityBio-secures-broad-UAE-authorization-for-ANKTIVA-in-bladder-and-lung-cancer-e1785384506177.webp https://pharmadevicenews.com/emeranova-partners-with-halo-biosystems-for-hyaluronic-acid-wound-technology/ PharmaDeviceNews en 2026-10-17T05:51:53+00:00 EmeraNova partners with Halo Biosystems for hyaluronic acid wound technology Andrew Dunn, BioLab Holdings, Burns, diabetic foot ulcers, EmeraNova, FDA, Halo Biosystems, HYAFF 11, Hyalomatrix, hyaluronic acid, Jaime Leija, Kent Imaging, Pressure Ulcers, Sweet Bio, Tissue Restoration, wound care https://pharmadevicenews.com/wp-content/uploads/2026/10/EmeraNova-partners-with-Halo-Biosystems-to-expand-Hyalomatrix-wound-care-access-scaled-e1792216260303.webp https://pharmadevicenews.com/alcons-new-eye-drops-last-up-to-12-hours-can-brytly-challenge-lumify/ PharmaDeviceNews en 2026-10-17T05:46:02+00:00 Alcon’s new eye drops last up to 12 hours. Can BRYTLY challenge Lumify? Alcon, Alpha Adrenergic Agonists, Apraclonidine, Bausch + Lomb, Brimonidine, BRYTLY, Consumer Eye Care, Eye Redness, FDA, Jonathan Balch, Lumify, ophthalmology, over-the-counter medicines, Systane https://pharmadevicenews.com/wp-content/uploads/2026/10/Alcon-BRYTLY-targets-redness-relief-within-one-minute-of-application-scaled-e1792215892639.webp https://pharmadevicenews.com/pelages-hair-loss-drug-showed-a-31-early-response-rate-can-600-patients-confirm-it/ PharmaDeviceNews en 2026-10-17T05:40:43+00:00 Pelage’s hair-loss drug showed a 31% early response rate. Can 600 patients confirm it? androgenetic alopecia, ARCH Venture Partners, AWAKEN, Christina Weng, Daniel Gil, FDA, finasteride, GV, Hair Follicle Stem Cells, minoxidil, Norwood-Hamilton Scale, Pelage Pharmaceuticals, PP405, regenerative medicine https://pharmadevicenews.com/wp-content/uploads/2026/04/Nektars-alopecia-areata-catalyst-is-here-what-52-week-rezpegaldesleukin-data-could-mean-for-Phase-3-e1776663142113.webp https://pharmadevicenews.com/one-antibody-could-target-both-eczema-inflammation-and-itching-zai-labs-first-human-results-are-coming/ PharmaDeviceNews en 2026-10-17T04:57:28+00:00 One antibody could target both eczema inflammation and itching. Zai Lab’s first human results are coming ACAAI 2026, American College of Allergy Asthma and Immunology, atopic dermatitis, bispecific antibodies, Dupilumab, Dupixent, Ebglyss, FDA, interleukin-13, Interleukin-31 Receptor Alpha, lebrikizumab, Nemluvio, nemolizumab, Rafael Amado, Zai Lab, ZL-1503 https://pharmadevicenews.com/wp-content/uploads/2026/06/Chronic-hand-eczemas-hidden-cost-emerges-in-DELTA-FORCE-and-DELTA-TEEN-data-e1782663756589.webp https://pharmadevicenews.com/four-of-eight-pancreatic-cancer-patients-responded-to-vs-7375-can-verastem-repeat-the-result-in-phase-3/ PharmaDeviceNews en 2026-10-17T04:54:09+00:00 Four of eight pancreatic cancer patients responded to VS-7375. Can Verastem repeat the result in Phase 3? colorectal cancer, Daniel Paterson, FDA, GenFleet Therapeutics, GFH375, KRAS G12D, Michael Kauffman, non-small cell lung cancer, pancreatic ductal adenocarcinoma, TARGET-D 101, TARGET-D 201, TARGET-D 202, TARGET-D 203, Verastem Oncology, VS-7375 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/pfizers-lyme-vaccine-showed-73-efficacy-but-missed-a-statistical-hurdle-what-comes-next/ PharmaDeviceNews en 2026-10-17T04:51:05+00:00 Pfizer’s Lyme vaccine showed 73% efficacy, but missed a statistical hurdle. What comes next? ABRYSVO, BioNTech, COMIRNATY, IDWeek 2026, LB6V, Lyme disease, PAXLOVID, PENBRAYA, PF-07307405, PF-07872412, Pfizer, Pneumococcal Disease, Prevnar 20, respiratory syncytial virus, Valneva, VALOR https://pharmadevicenews.com/wp-content/uploads/2026/05/Modernas-hantavirus-vaccine-signal-exposes-the-next-test-for-mRNA-confidence-e1778345794941.webp