https://pharmadevicenews.com/asundexian-failed-in-atrial-fibrillation-then-became-the-first-factor-xia-drug-approved-what-did-bayer-get-right/ PharmaDeviceNews en 2026-11-11T07:24:17+00:00 Asundexian failed in atrial fibrillation, then became the first Factor XIa drug approved. What did Bayer get right? asundexian, Bayer AG, LIBREXIA-STROKE, milvexian, OCEANIC-AF, OCEANIC-STROKE, Sunharbo, United States Food and Drug Administration, Xarelto https://pharmadevicenews.com/wp-content/uploads/2025/12/pharmadevicenews-1.png https://pharmadevicenews.com/can-sunharbo-become-bayers-next-cardiovascular-blockbuster-after-xarelto/ PharmaDeviceNews en 2026-11-11T07:21:36+00:00 Can Sunharbo become Bayer’s next cardiovascular blockbuster after Xarelto? asundexian, Bayer, OCEANIC-AF, OCEANIC-STROKE, Sunharbo, U.S. Food and Drug Administration, Xarelto https://pharmadevicenews.com/wp-content/uploads/2026/06/Penumbra-THUNDERBOLT-FDA-clearance-raises-the-stakes-in-stroke-thrombectomy-technology-e1781242935321.webp https://pharmadevicenews.com/biogen-and-ucbs-lupus-drug-reached-sustained-remission-in-more-patients-why-the-real-test-is-still-two-years-away/ PharmaDeviceNews en 2026-11-11T07:18:22+00:00 Biogen and UCB’s lupus drug reached sustained remission in more patients. Why the real test is still two years away American College of Rheumatology, AstraZeneca, Benlysta, Biogen Inc., dapirolizumab pegol, GSK, PHOENYCS FLY, PHOENYCS GO, Saphnelo, UCB SA https://pharmadevicenews.com/wp-content/uploads/2026/10/Autoimmune-disease-research-e1793144740150.webp https://pharmadevicenews.com/caplyta-improved-bipolar-mania-by-day-3-in-two-phase-3-trials-can-johnson-johnson-unlock-another-blockbuster-indication/ PharmaDeviceNews en 2026-11-11T07:15:09+00:00 CAPLYTA improved bipolar mania by Day 3 in two Phase 3 trials. Can Johnson & Johnson unlock another blockbuster indication? CAPLYTA, Intra-Cellular Therapies, Johnson & Johnson, lumateperone, Study 451, Study 452, U.S. Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-Generic-Image.webp https://pharmadevicenews.com/argenx-just-committed-up-to-1-15bn-to-a-biotech-with-no-disclosed-clinical-drug-what-is-it-really-buying/ PharmaDeviceNews en 2026-11-11T04:13:46+00:00 argenx just committed up to $1.15bn to a biotech with no disclosed clinical drug. What is it really buying? argenx, Cameron Pye, FB102, Forte Biosciences, Karen Massey, Unnatural Products, Vyvgart https://pharmadevicenews.com/wp-content/uploads/2025/12/pharmadevicenews-1.png https://pharmadevicenews.com/optune-mya-doubled-median-time-to-brain-progression-why-did-the-fda-still-refuse-to-approve-it/ PharmaDeviceNews en 2026-11-11T03:51:10+00:00 Optune Mya doubled median time to brain progression. Why did the FDA still refuse to approve it? METIS, NovoCure Limited, Optune Gio, Optune Lua, Optune Mya, Tumor Treating Fields, United States Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/09/ChatGPT-Image-Sep-13-2026-08_31_27-PM-e1789311742102.webp https://pharmadevicenews.com/roche-wants-to-treat-alzheimers-before-memory-loss-begins-can-a-blood-test-and-brainshuttle-antibody-make-prevention-possible/ PharmaDeviceNews en 2026-11-11T03:47:17+00:00 Roche wants to treat Alzheimer’s before memory loss begins. Can a blood test and Brainshuttle antibody make prevention possible? Clinical Trials on Alzheimer’s Disease, Elecsys pTau217, F. Hoffmann-La Roche Ltd, Genentech, PrevenTRON, RG6434, Roche Diagnostics, TARBELA-AD, TRONTIER, trontinemab, United States Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-Diagnostics-generic-image.webp https://pharmadevicenews.com/foundayo-cut-sleep-apnea-events-by-44-without-pap-can-lilly-turn-an-obesity-pill-into-its-next-osa-franchise/ PharmaDeviceNews en 2026-11-11T03:42:59+00:00 Foundayo cut sleep apnea events by 44% without PAP. Can Lilly turn an obesity pill into its next OSA franchise? ATTAIN-OSA, Chugai Pharmaceutical Co. Ltd., Eli Lilly and Company, Foundayo, orforglipron, tirzepatide, U.S. Food and Drug Administration, Zepbound https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-tablets-generic-e1788149113473.webp https://pharmadevicenews.com/what-boehringers-survodutide-cardiovascular-trial-means-for-obesity-approval/ PharmaDeviceNews en 2026-11-10T07:25:19+00:00 What Boehringer’s survodutide cardiovascular trial means for obesity approval American Heart Association, Boehringer Ingelheim, LIVERAGE, survodutide, SYNCHRONIZE-CVOT, The Lancet, Zealand Pharma https://pharmadevicenews.com/wp-content/uploads/2026/07/Ionis-and-AstraZenecas-eplontersen-misses-Phase-3-endpoint-in-ATTR-CM-e1783921352857.webp https://pharmadevicenews.com/piktor-controlled-disease-in-83-of-patients-so-why-did-faeth-therapeutics-stock-crash-42/ PharmaDeviceNews en 2026-11-10T07:12:30+00:00 PIKTOR controlled disease in 83% of patients, so why did Faeth Therapeutics stock crash 42%? Faeth Therapeutics, GOG-3111, PIK-201, PIKTOR, sapanisertib, serabelisib, The GOG Foundation, U.S. Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/08/Faeth-Therapeutics-PIKTOR-PK-PD-modeling-supports-Phase-2-dose-in-endometrial-cancer-e1786248083528.webp https://pharmadevicenews.com/johnson-johnson-cut-psa-by-at-least-50-in-73-of-heavily-treated-patients-can-two-bispecifics-crack-prostate-cancer/ PharmaDeviceNews en 2026-11-10T03:39:04+00:00 Johnson & Johnson cut PSA by at least 50% in 73% of heavily treated patients. Can two bispecifics crack prostate cancer? JNJ-87189401, JNJ-9401, Johnson & Johnson, KLK2-comPAS, pasritamig, Society for Immunotherapy of Cancer https://pharmadevicenews.com/wp-content/uploads/2026/10/Prostate-cancer-research-e1793137215571.webp https://pharmadevicenews.com/bimzelx-beat-abbvies-us5-8bn-a-quarter-skyrizi-on-joint-response-why-ucb-still-cannot-claim-broad-superiority/ PharmaDeviceNews en 2026-11-10T03:36:23+00:00 BIMZELX beat AbbVie’s US$5.8bn-a-quarter SKYRIZI on joint response. Why UCB still cannot claim broad superiority AbbVie Inc., American College of Rheumatology, BE BOLD, bimekizumab, BIMZELX, risankizumab, SKYRIZI, UCB SA https://pharmadevicenews.com/wp-content/uploads/2026/07/Forte-Biosciences-acquisition-puts-FB102-clinical-development-at-centre-of-argenx-growth-strategy-e1785132168268.webp https://pharmadevicenews.com/sapphiros-and-binx-health-combine-as-onvaro-around-1000-device-diagnostics-network/ PharmaDeviceNews en 2026-11-10T03:32:20+00:00 Sapphiros and binx health combine as Onvaro around 1,000-device diagnostics network binx health, binx io, EQT Life Sciences, Hildred, KKR, Onvaro, Sapphiros, U.S. Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/08/PDN-Diagnostics-2-generic-1.webp https://pharmadevicenews.com/amsoki-cel-produced-responses-in-two-thirds-of-advanced-melanoma-patients-can-obsidian-make-til-therapy-easier-to-deliver/ PharmaDeviceNews en 2026-11-10T03:24:32+00:00 Amsoki-cel produced responses in two-thirds of advanced melanoma patients. Can Obsidian make TIL therapy easier to deliver? Agni-01, amsoki-cel, amsokigene autoleucel, Amtagvi, Iovance Biotherapeutics, lifileucel, Obsidian Therapeutics, OBX-115, Society for Immunotherapy of Cancer, United States Food and Drug Administration https://pharmadevicenews.com/wp-content/uploads/2026/08/Replimune-Groups-RP1-plus-nivolumab-e1785635720248.webp