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MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease2025-11-29 • manilatimes.net
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen”) announced today that Eisai has filed a new drug application for "LEQEMBI®” (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).2025-11-29 • investors.biogen.com
Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan2025-11-28 • PR Newswire
Inaticabtagene Autoleucel (YORWIDATM) New Drug Application for Lymphoma Approved, China's innovative CAR-T Enters a New Era of Dual Indications2025-11-27 • psychiatrictimes.com
New Drug Application Submitted for Centanafidine for Treatment of ADHD2025-11-20 • PR Newswire
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics Initiate Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Zipalertinib for Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations2025-11-20 • PR Newswire
Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC2025-11-19 • manilatimes.net
Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer2025-11-19 • psychiatrictimes.com
Planned FDA Investigational New Drug Application: SPC-15 for the Treatment of PTSD2025-11-19 • stocktitan.net
Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer2025-11-18 • stocktitan.net
Silo Pharma Partners with Allucent to Support Planned FDA Investigational New Drug Application for SPC-15 as a Therapeutic for PTSD2025-11-17 • cancernetwork.com
FDA Accepts New Drug Application for 177Lu-Edotreotide in GEP-NETs2025-11-14 • globenewswire.com
ITM Announces FDA Acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a. 177Lu-edotreotide (ITM-11) in Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)2025-11-10 • neurologylive.com
Supplemental New Drug Application Submitted for AXS-05 as Treatment for Alzheimer Disease Agitation2025-11-05 • PR Newswire
FDA Issues Complete Response Letter for Biohaven's VYGLXIA (troriluzole) New Drug Application for Spinocerebellar Ataxia2 hours ago • newswire.ca
NORTH AMERICAN INDUSTRIAL GASES INC. - Early Warning Report Filed Pursuant to National Instrument 62-1033 hours ago • prnewswire.co.uk
Brainomix Announces New Study Published in Lancet Digital Health Demonstrating Impact of Brainomix 360 Stroke to Increase Endovascular Thrombectomy Rates3 hours ago • newswire.ca
Bridgemark Group Securities Litigation5 hours ago • prnewswire.co.uk
Kroll Elevates Global MDR Services, Migrating Protection to CrowdStrike Falcon Complete Next-Gen MDR6 hours ago • prnewswire.co.uk
Sustainable Markets Initiative Hosts Landmark Private Capital Mobilization Convening in London, with a report back session attended by His Majesty King Charles III9 hours ago • gurufocus.com
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Luigi Mangione Due Court Pretrial Hearings Over Us Healthcare Executives Killing 2025 12 019 hours ago • countryherald.com
Pope County Ar Drug Bust 448 Lbs Of Illegal Marijuana Seized After I 40 Traffic Stop9 hours ago • thedefensepost.com
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Edwards & Ragatz, P.A. Ranked Among Top 100 Wrongful Death Verdicts in the United States2 hours ago • EIN Presswire
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Elite Academic Academy Featured on 'All Access with Andy Garcia' as Showcasing the Future of Education10 hours ago • navalnews.com
Russian Navys Kharabovsk Special Purpose Submarine Hits The Water2025-12-01 • militarnyi.com
Explosions Reported In Kaspiysk Near Torpedo And Naval Engine Manufacturer10 hours ago • armyrecognition.com
Kalashnikov Expands Russia’s UAV Arsenal with New Line Based on Archangel Drone Project.9 hours ago • exchange4media.com
Kartik Sharma named Omnicom Media India CEO, Amardeep Singh appointed COO9 hours ago • punemirror.com
Pune River Cleanup Bhide Bridge 200kg Waste Removed9 hours ago • indianexpress.com
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NX London Hostel Announces Seasonal Discount to Support Winter Travellers7 hours ago • EIN Presswire
Krzysztof Ignaszak Sets a New Standard in Performance Marketing With Click Hive’s Data-Driven Growth Approach9 hours ago • enlit.world
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