https://www.biopharmawatch.com/news/PFE/pfizer-webcast-november-3-conference-call BiopharmaWatch en 2026-09-22T14:00:00.000Z Pfizer Invites Public to View and Listen to Webcast of November 3 Conference Call with Analysts https://www.biopharmawatch.com/news/TAK/takeda-esmo-2026-oncology-pipeline-progress BiopharmaWatch en 2026-09-22T13:30:00.000Z Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor Portfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921) Data, at ESMO 2026 https://www.biopharmawatch.com/news/RLAY/x-chem-phase-3-milestone-relay-therapeutics BiopharmaWatch en 2026-09-22T13:30:00.000Z X-Chem Announces Phase 3 Milestone in Collaboration with Relay Therapeutics https://www.biopharmawatch.com/news/LNAI/lunai-bioworks-expands-parkinsons-platform-tanaist-agreement BiopharmaWatch en 2026-09-22T13:20:00.000Z Lunai Bioworks (NASDAQ: LNAI) Expands Parkinson's Platform Through Exclusive Tanaist Agreement https://www.biopharmawatch.com/news/LGND/sydnexis-royalty-agreement-ligand-ryjunea BiopharmaWatch en 2026-09-22T13:02:00.000Z Sydnexis Announces Royalty Agreement with Ligand for Ryjunea® https://www.biopharmawatch.com/news/TECH/bio-techne-customer-experience-center-duesseldorf BiopharmaWatch en 2026-09-22T13:00:00.000Z Bio-Techne Opens New Customer Experience Center in Düsseldorf to Accelerate Scientific Discovery and Customer Collaboration https://www.biopharmawatch.com/news/AMGN/amgen-positive-topline-phase-3-results-dazodalibep-sjogrens BiopharmaWatch en 2026-09-22T13:00:00.000Z AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR DAZODALIBEP IN MODERATE-TO-SEVERE SYSTEMIC SJÖGREN'S DISEASE https://www.biopharmawatch.com/news/OPTH/optimi-health-appoints-dr-michael-blough-cdo BiopharmaWatch en 2026-09-22T13:00:00.000Z Optimi Health Appoints Dr. Michael Blough as Chief Clinical Development Officer https://www.biopharmawatch.com/news/RVMD/ampligen-role-pancreatic-cancer-treatment-fda-approval BiopharmaWatch en 2026-09-22T12:55:00.000Z AIM ImmunoTech Highlights Ampligen’s Potential Role in the Evolving Pancreatic Cancer Treatment Landscape Following FDA Approval of Revolution Medicines’ Daraxonrasib https://www.biopharmawatch.com/news/MAIA/maia-biotechnology-phase-3-trial-nsclc-progress BiopharmaWatch en 2026-09-22T12:47:00.000Z MAIA Biotechnology Reports Pivotal Phase 3 Clinical Trial Progress in Advanced Non-Small Cell Lung Cancer https://www.biopharmawatch.com/news/ONMD/onemednet-expands-commercial-reach-atropus-health BiopharmaWatch en 2026-09-22T12:40:00.000Z OneMedNet Expands Commercial Reach Through Multi-Year Resale Agreement with Atropos Health https://www.biopharmawatch.com/news/PALI/palisade-bio-fda-clearance-ind-pali-2108-crohns-disease BiopharmaWatch en 2026-09-22T12:35:00.000Z Palisade Bio Receives FDA Clearance of IND for PALI-2108 in Crohn’s Disease, Expanding Phase 2 Development Across IBD https://www.biopharmawatch.com/news/PLRZ/polyrizon-first-patient-nasarix-allergy-blocker BiopharmaWatch en 2026-09-22T12:33:00.000Z Polyrizon Enrolls First Patient in U.S. Clinical Study of NASARIX (PL-14) Allergy Blocker https://www.biopharmawatch.com/news/INCY/incyte-eadv-congress-inflammation-autoimmunity-portfolio BiopharmaWatch en 2026-09-22T12:30:00.000Z Incyte Data at the European Academy of Dermatology and Venereology (EADV) Congress Underscore the Breadth of Incyte’s Inflammation and Autoimmunity Portfolio https://www.biopharmawatch.com/news/QTI/qt-imaging-honored-premier-supplier-innovation BiopharmaWatch en 2026-09-22T12:30:00.000Z QT Imaging to be Honored at Premier’s Annual Supplier Innovation Celebration https://www.biopharmawatch.com/news/RCUS/arcus-biosciences-investor-event-casdatifan-kidney-cancer BiopharmaWatch en 2026-09-22T12:30:00.000Z Arcus Biosciences to Host Investor Event Featuring New Data for Casdatifan as a Treatment for Kidney Cancer Across Multiple Lines of Therapy https://www.biopharmawatch.com/news/APRE/aprea-therapeutics-phase-1-data-eortc-nci-aacr-symposium BiopharmaWatch en 2026-09-22T12:30:00.000Z Aprea Therapeutics to Present Updated Interim Phase 1 Data on WEE1 Inhibitor APR-1051 in an Oral Presentation at 38th EORTC-NCI-AACR Symposium https://www.biopharmawatch.com/news/CMPX/compass-therapeutics-regulatory-update-tovecimig-btc BiopharmaWatch en 2026-09-22T12:30:00.000Z Compass Therapeutics Provides Regulatory Update on Tovecimig in Biliary Tract Cancer Following FDA Feedback https://www.biopharmawatch.com/news/QNRX/quoin-pharmaceuticals-fda-fast-track-qrx003-peeling-skin-syndrome BiopharmaWatch en 2026-09-22T12:30:00.000Z Quoin Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling Skin Syndrome https://www.biopharmawatch.com/news/PPCB/propanc-biopharma-prp-cancer-data-eras-0015 BiopharmaWatch en 2026-09-22T12:30:00.000Z Propanc Biopharma Highlights Differentiated PRP Pancreatic Cancer Data Versus Emerging Pan-RAS Program ERAS-0015 https://www.biopharmawatch.com/news/SCNX/scienture-expands-rezenopy-distribution-addiction-centers BiopharmaWatch en 2026-09-22T12:15:00.000Z SCIENTURE Expands Commercial Reach of REZENOPY™ to Addiction Treatment Centers through an Agreement with a Distribution Partner https://www.biopharmawatch.com/news/IMNN/imunon-phase-2-mrd-study-imnn-001-update BiopharmaWatch en 2026-09-22T12:05:00.000Z IMUNON Reports Independent Data Monitoring Committee Recommends Continued Phase 2 Development of IMNN-001 Following Favorable Safety Review https://www.biopharmawatch.com/news/RNAZ/transcode-therapeutics-patent-advancements-australia-japan BiopharmaWatch en 2026-09-22T12:04:00.000Z TransCode Therapeutics Announces Patent Advancements in Australia and Japan Strengthening Global IP Position in RNA-Based Immuno-Oncology https://www.biopharmawatch.com/news/LNTH/lantheus-fda-approval-bravnetsa-gastroenteropancreatic-neuroendocrine-tumors BiopharmaWatch en 2026-09-22T12:00:00.000Z Lantheus Receives Final FDA Approval for BRAVNETSA™ (Lutetium Lu 177 Dotatate), the Only Radiopharmaceutical FDA has Determined to be Bioequivalent and Therapeutically Equivalent to LUTATHERA® for the Treatment of GEP-NETs https://www.biopharmawatch.com/news/NTRA/signatera-regulatory-approval-japan-bladder-cancer BiopharmaWatch en 2026-09-22T12:00:00.000Z Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic in Muscle-Invasive Bladder Cancer https://www.biopharmawatch.com/news/BIAF/bioaffinity-technologies-cypath-lung-navref-2026 BiopharmaWatch en 2026-09-22T12:00:00.000Z bioAffinity Technologies to Present Positive Clinical and Veteran-Focused Data on CyPath® Lung at NAVREF 2026 Annual Conference https://www.biopharmawatch.com/news/VRTX/vertex-positive-results-amplified-study-inaxaplin BiopharmaWatch en 2026-09-22T12:00:00.000Z Vertex Announces Positive Results From Phase 2b AMPLIFIED Study of Inaxaplin in Additional Populations of People With APOL1-Mediated Kidney Disease (AMKD) and Completion of Enrollment in the Phase 2/3 AMPLITUDE Trial https://www.biopharmawatch.com/news/TRLV/trulieve-added-to-sp-indices BiopharmaWatch en 2026-09-22T12:00:00.000Z Trulieve Cannabis Corp. Added to S&P Total Market and S&P Completion Indices https://www.biopharmawatch.com/news/ENLV/enlivex-terminates-financing-rain-tokens BiopharmaWatch en 2026-09-22T12:00:00.000Z Enlivex Announces Termination of Previously-Announced Financing Payable in RAIN Tokens https://www.biopharmawatch.com/news/FLNA/filana-therapeutics-fda-lift-clinical-hold-simufilam BiopharmaWatch en 2026-09-22T12:00:00.000Z Filana Therapeutics Announces FDA Lift of Clinical Hold on Simufilam, Enabling Phase 2a Study in TSC-Related Epilepsy https://www.biopharmawatch.com/news/RYTM/rhythm-pharmaceuticals-health-canada-approval-imcivree BiopharmaWatch en 2026-09-22T12:00:00.000Z Rhythm Pharmaceuticals Announces Health Canada Approval of IMCIVREE® (setmelanotide) for Weight Management in Adult and Pediatric Patients 4 years of Age and Older with Acquired Hypothalamic Obesity https://www.biopharmawatch.com/news/ADAG/adagene-nmpa-clearance-adg138-bispecific-engager BiopharmaWatch en 2026-09-22T12:00:00.000Z Adagene Announces NMPA Clearance of Investigational New Drug Application for ADG138, a Novel HER2xCD3 Double-Masked Bispecific T-Cell Engager https://www.biopharmawatch.com/news/MRKR/marker-therapeutics-manufacturing-support-kincellis-advanced-therapies BiopharmaWatch en 2026-09-22T12:00:00.000Z Marker Therapeutics Highlights Expanded Manufacturing Support of CDMO Partner Following Formation of Kincellis Advanced Therapies https://www.biopharmawatch.com/news/SCYX/scynexis-appoints-steven-burke-board-directors BiopharmaWatch en 2026-09-22T12:00:00.000Z SCYNEXIS Appoints Seasoned Industry Veteran Steven K. Burke, M.D., to its Board of Directors https://www.biopharmawatch.com/news/SNN/smith-nephew-fda-clearance-landmark-knee-system BiopharmaWatch en 2026-09-22T12:00:00.000Z Natural design. 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Integrate the iLet® Bionic Pancreas and mint™ with Senseonics’ Eversense® 365 https://www.biopharmawatch.com/news/VKTX/viking-therapeutics-vk2735-maintenance-study-results BiopharmaWatch en 2026-09-22T11:05:00.000Z Viking Therapeutics Announces Positive Topline Results from Maintenance Study of GLP-1/GIP Agonist VK2735 Demonstrating the Promise of Multiple Maintenance Dosing Regimens https://www.biopharmawatch.com/news/ZBIO/zenas-biopharma-obexelimab-presentations-igg4-rd BiopharmaWatch en 2026-09-22T11:05:00.000Z Zenas BioPharma Announces Upcoming Presentations of Obexelimab Data in IgG4-Related Disease at the IgG4ward! 6th International Symposium on IgG4-Related Disease and ACR Convergence 2026 https://www.biopharmawatch.com/news/KIDS/orthopediatrics-1000-pnp-tibia-nail-implantations BiopharmaWatch en 2026-09-22T11:05:00.000Z OrthoPediatrics Surpasses 1,000 PNP Tibia Nail Implantations https://www.biopharmawatch.com/news/JNJ/chmp-recommends-tecvayli-approval-johnson-johnson BiopharmaWatch en 2026-09-22T11:01:00.000Z Der CHMP empfiehlt die Zulassung von TECVAYLI®▼ (teclistamab) von Johnson & Johnson zur Behandlung des rezidivierten bzw. refraktären multiplen Myeloms nach mindestens einer vorherigen Therapie https://www.biopharmawatch.com/news/ELDN/eledon-phase-2-bestow-study-results BiopharmaWatch en 2026-09-22T11:00:00.000Z Eledon Presents Updated Long-Term Phase 2 BESTOW Extension Study Results at the International Congress of The Transplantation Society https://www.biopharmawatch.com/news/CSTL/castle-biosciences-new-laboratory-facility-scottsdale BiopharmaWatch en 2026-09-22T11:00:00.000Z Castle Biosciences to Open New Laboratory Facility in Scottsdale https://www.biopharmawatch.com/news/CGEN/compugen-virtual-kol-event-com701-ovarian-cancer-update BiopharmaWatch en 2026-09-22T11:00:00.000Z Compugen to Host Virtual KOL Event on COM701 in Ovarian Cancer & Unigen™ Platform Update on October 5, 2026 https://www.biopharmawatch.com/news/EWTX/edgewise-therapeutics-edg-7500-mechanism-action BiopharmaWatch en 2026-09-22T11:00:00.000Z Edgewise Therapeutics Unveils the Differentiated Mechanism of Action (MoA) of its Cardiac Sarcomere Modulator EDG-7500 https://www.biopharmawatch.com/news/TNXP/tonix-pharmaceuticals-tonmya-medicare-agreement BiopharmaWatch en 2026-09-22T11:00:00.000Z Tonix Pharmaceuticals Announces Second Major Managed Medicare Payer Agreement for TONMYA® https://www.biopharmawatch.com/news/LXEO/lexeo-therapeutics-acquires-mantle-therapeutics BiopharmaWatch en 2026-09-22T11:00:00.000Z Lexeo Therapeutics Enters Into Agreement to Acquire Mantle Therapeutics and Announces Multiple New Strategic Collaborations to Expand Leadership in Friedreich Ataxia https://www.biopharmawatch.com/news/MDWD/medi-wound-awarded-funding-nexobrid-development BiopharmaWatch en 2026-09-22T11:00:00.000Z MediWound Awarded Additional $3.3 Million from U.S. Department of War to Advance Room-Temperature-Stable Formulation of NexoBrid® https://www.biopharmawatch.com/news/CLDX/celldex-positive-results-phase-3-barzolvolimab BiopharmaWatch en 2026-09-22T10:58:00.000Z Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints https://www.biopharmawatch.com/news/MRK/fda-approves-winrevair-label-update-hyperion-trial BiopharmaWatch en 2026-09-22T10:45:00.000Z U.S. FDA Approves Update to the Label for WINREVAIR™ (sotatercept-csrk) to Include Data from the Phase 3 HYPERION Trial Evaluating Adults Recently Diagnosed with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension) https://www.biopharmawatch.com/news/SMMT/harmoni-gi1-phase-iii-trial-esmo-2026 BiopharmaWatch en 2026-09-22T10:00:00.000Z HARMONi-GI1, a Phase III Trial Featuring Ivonescimab Plus Chemotherapy Compared to Durvalumab Plus Chemotherapy in First-Line Treatment of Patients with Advanced Biliary Tract Cancer from China, to Be Showcased in Presidential Symposium at ESMO 2026 https://www.biopharmawatch.com/news/ABBV/abbvie-eu-approval-rinvoq-pjia-treatment BiopharmaWatch en 2026-09-22T06:00:00.000Z AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Children with Active Polyarticular Juvenile Idiopathic Arthritis https://www.biopharmawatch.com/news/PHAR/pharming-leniolisib-positive-phase-ii-data-esid-2026 BiopharmaWatch en 2026-09-22T05:00:00.000Z Pharming announces positive Phase II topline data for leniolisib in PIDs with immune dysregulation accepted as late-breaking abstract at ESID 2026 https://www.biopharmawatch.com/news/NVS/boomray-novartis-license-agreement-radioligand-therapy BiopharmaWatch en 2026-09-22T04:00:00.000Z BoomRay Enters Exclusive Global License Agreement with Novartis for a Novel Radioligand Therapy Asset https://www.biopharmawatch.com/news/AYTU/aytu-biopharma-fiscal-2026-results-report BiopharmaWatch en 2026-09-22T00:00:00.000Z Aytu BioPharma to Report Fiscal 2026 Full Year and Fourth Quarter Operational and Financial Results on September 22, 2026 https://www.biopharmawatch.com/news/HELP/helus-pharma-td-cowen-summit-participation BiopharmaWatch en 2026-09-21T21:15:07.000Z Helus Pharma to Participate at the TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit https://www.biopharmawatch.com/news/BDX/arthur-hu-joins-bd-as-chief-information-officer BiopharmaWatch en 2026-09-21T20:30:00.000Z Arthur Hu to Join BD as Chief Information and Digital Officer https://www.biopharmawatch.com/news/PTCT/ptc-acquisition-st-920-fabry-gene-therapy BiopharmaWatch en 2026-09-21T20:30:00.000Z PTC Completes Acquisition of ST-920 Fabry Disease Gene Therapy https://www.biopharmawatch.com/news/CVKD/cadrenal-therapeutics-lytham-partners-fall-2026-conference BiopharmaWatch en 2026-09-21T20:30:00.000Z Cadrenal Therapeutics to Participate in the Lytham Partners Fall 2026 Investor Conference https://www.biopharmawatch.com/news/ANAB/anaptysbio-q2-2026-financial-results-update BiopharmaWatch en 2026-09-21T20:15:00.000Z Anaptys Announces Second Quarter and Transitional Fiscal Year 2026 Financial Results and Provides Business Update https://www.biopharmawatch.com/news/TVTX/travere-therapeutics-ceo-transition BiopharmaWatch en 2026-09-21T20:05:00.000Z Travere Therapeutics Announces Planned Chief Executive Officer Transition https://www.biopharmawatch.com/news/ABVX/abivax-business-updates-first-half-2026-results BiopharmaWatch en 2026-09-21T20:05:00.000Z Abivax Presents Business Updates and First Half 2026 Financial Results https://www.biopharmawatch.com/news/NYXH/nyxoah-cfo-transition-2026 BiopharmaWatch en 2026-09-21T20:01:00.000Z Nyxoah Announces Chief Financial Officer Transition https://www.biopharmawatch.com/news/XENE/xenon-presents-td-cowen-summit BiopharmaWatch en 2026-09-21T20:01:00.000Z Xenon to Present at TD Cowen Novel Mechanisms in Neuropsychiatry & Epilepsy Summit https://www.biopharmawatch.com/news/NAMS/menarini-newamsterdam-eu-approval-ubeslo-evlarco BiopharmaWatch en 2026-09-21T19:04:00.000Z Menarini Group und NewAmsterdam Pharma erhalten von der Europäischen Kommission die Zulassung für Ubeslo® (Obicetrapib als Monotherapie) und Evlarco® (Fixkombination aus Obicetrapib und Ezetimib) https://www.biopharmawatch.com/news/HYFT/mindwalk-openfold3-deployment-amd-vultr BiopharmaWatch en 2026-09-21T18:03:00.000Z MindWalk met OpenFold3 en production en quelques minutes grâce aux microservices d’inférence AMD sur Vultr Kubernetes Engine https://www.biopharmawatch.com/news/CGEM/cullinan-therapeutics-stifel-2026-forum BiopharmaWatch en 2026-09-21T16:00:00.000Z Cullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum https://www.biopharmawatch.com/news/NAMS/menarini-newamsterdam-european-approval-ubicetrapib BiopharmaWatch en 2026-09-21T14:57:00.000Z Menarini Group and NewAmsterdam Pharma Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) https://www.biopharmawatch.com/news/SNN/smith-nephew-showcase-shoulder-technologies-icses-2026 BiopharmaWatch en 2026-09-21T14:00:00.000Z Smith+Nephew to showcase leading shoulder technologies for joint repair and reconstruction at ICSES 2026 https://www.biopharmawatch.com/news/GRML/greenland-mines-sarfartoq-expansion BiopharmaWatch en 2026-09-21T13:30:00.000Z Greenland Mines More Than Doubles Control Position in the Sarfartoq Rare Earth Magnet District in West Greenland https://www.biopharmawatch.com/news/QTTB/q32-bio-signals-results-bempikibart-eadv-2026 BiopharmaWatch en 2026-09-21T13:15:00.000Z Q32 Bio Announces Upcoming Late-Breaking Presentation of Results from Part B of the SIGNAL-AA Clinical Trial of Bempikibart in Alopecia Areata at the European Academy of Dermatology and Venereology Congress 2026 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