Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Pilatus Biosciences Advances PLT012 Into the Clinic Following FDA IND Clearance; ENHERTU + pertuzumab Receives US Approval as the First New First-line Option in a Decade for HER2-positive Metastatic Breast Cancer; Sanofi Reports on Tolebrutinib Development in Primary Progressive MS; Gilead Reports Positive Phase 3 Results for Bictegravir–Lenacapavir Investigational HIV Therapy; argenx Announces Study Update for UplighTED Program of Efgartigimod SC in Thyroid Eye Disease

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medtech-news-for-bendit-proverum-medint

Bendit Received FDA Clearance for the Bendit17™ Steerable Microcatheter; ProVee System Receives FDA Approval as a New-Era Prostatic Urethral Stent for BPH; a2z Radiology AI Secures $4.5M Seed Funding to Advance Full-Spectrum CT Analysis; MedINT Introduces Advanced Medical AI System Integrating Clinician Oversight; Nitinotes Treats First Patient in Pivotal EASE™ Trial of the EndoZip™ Automated Suturing System for ESG; Airiver Medical Secures FDA IDE Authorization to Launch Pivotal CRS Clinical Trial

pharma-news-for-kallyope-ideaya-ayrmid

Kallyope’s Elismetrep Achieves Primary and Secondary Endpoints in Phase 2b Clinical Study; IDEAYA Secures IND Approval to Initiate Clinical Evaluation of IDE034; OMISIRGE Receives FDA Approval; Agios Updates on Regulatory Path for Mitapivat to Treat Thalassemia; Mirum to Acquire Bluejay Therapeutics

pharma-news-for-novo-ascendis-otsuka

Novo Nordisk Seeks FDA Approval for Higher-Dose 7.2 mg WEGOVY Injection; Ascendis Pharma Granted FDA Review Extension for TransCon CNP in Children with Achondroplasia; VOYXACT Receives FDA Fast-Track Approval for Treatment of High-Risk Primary IgAN; Sarepta Begins Next ENDEAVOR Cohort Focused on Immunosuppressive Optimization for ELEVIDYS in Advanced DMD; IMFINZI Gains U.S. Approval as the Sole Perioperative Immunotherapy for Early-Stage Gastric and GEJ Cancer

medtech-news-for-bd-rapidai-ceribell

Bracco Receives FDA Clearance for Additional Clinical Use of Max 3™ Syringeless MR Injector; RapidAI Broadens Clinical AI Portfolio with Five Newly Granted FDA Clearances; Ceribell Secures FDA 510(k) Clearance for Clarity® Algorithm in Neonatal Care; BD Introduces Surgiphor™ Irrigation System Across Europe to Enhance Surgical Patient Protection; Neurophet and The Florey Announce Strengthened Collaboration to Advance Alzheimer’s Diagnostic Solutions; VSI® Performs First-Ever Robotic Minimally Invasive Bertolotti’s Resection; BioWave® Demonstrates Safe and Effective Home-Based and War Injury Pain Relief in Latest Clinical Data

pharma-news-for-novartis-bayer-novo

Novartis Secures FDA Approval for ITVISMA; Kelun-Biotech’s Phase III Study Shows Sac-TMT + Keytruda Achieves Primary Endpoint in First-Line PD-L1-Positive NSCLC; Evoke Phase 3 Trials Failed to Show a Statistically Significant Impact on Alzheimer’s Disease Progression; Sangamo Therapeutics Gets FDA Nod for Rolling BLA Submission of ST-920 in Fabry Disease; Bayer’s HYRNUO Receives FDA Accelerated Approval for Previously Treated HER2-mutant NSCLC

medtech-news-for-zimmer-biomet-icecure-clairity

Zimmer Biomet Secures FDA Clearance for Upgraded ROSA® Knee Robotic System; IceCure’s ProSense® Cryoablation Platform Secures Swissmedic Approval for Use in Breast, Lung, Liver, and Kidney Tumors; Clairity Secures $43M Series B to Launch FDA-Authorized AI Platform for Breast Cancer Risk Prediction; Distalmotion Secures $150M to Boost U.S. Rollout of DEXTER® Robotic Surgery System; Envoy Medical Reaches Six-Month Benchmark with First 10 Patients in Acclaim® Cochlear Implant Trial; Cardiovalve Seeks CE Approval After Positive TARGET Study Results

pharma-news-for-sarepta-merck-bms

Sarepta Secures FDA Approval of Revised Prescribing Information for ELEVIDYS; Merck to Acquire Cidara Therapeutics; BMS & J&J Halt Milvexian Phase III in ACS After Interim Review; Kura Oncology & Kyowa Kirin Win FDA Green Light for KOMZIFTI in NPM1-Mutated AML; Novartis’ Phase III KLU156 (GanLum) Trial Hits Primary Endpoint

medtech-news-for-nitinotes-meduloc-kaneka

Nitinotes Obtains CE Mark Approval for EndoZip™ System; FDA Grants 510(k) for Meduloc’s Innovative Fixation Solution for Small and Long Bones; Kaneka Launches i-ED COIL™ in Europe; Motive Health Unveils New At-Home Therapy for Lower Back Relief; Gore Reports Strong 12-Month Results for VIABAHN® FORTEGRA Venous Stent in Iliocaval Disease; Vexev Marks Completion of Enrollment in AV Fistula Mapping Clinical Study

pharma-news-for-cogent-biosciences-anaptys-eledon

Cogent Biosciences’ Bezuclastinib Phase 3 PEAK Trial Positive Results for GIST; Domain Therapeutics Begins Phase I/II Trial of CCR8 Inhibitor DT-7012 in Solid Tumors; Anaptys Reports Negative Phase 2 Outcomes for Rosnilimab in Ulcerative Colitis; QOL Medical Strikes Deal to Acquire Evoke Pharma for $11 Cash Per Share; Eledon Pharmaceuticals, Inc. Unveils Phase 2 BESTOW Trial Data for Tegoprubart in Kidney Transplant Rejection Prevention at ASN Kidney Week 2025

medtech-news-for-nexalin-technology-elevaris-bd

Nexalin Technology Secures Israeli Regulatory Clearance for Gen-2 SYNC 15 mA DIFS™ Neurostimulation System; W&H Medical Launches First U.S.–Cleared Piezo & Drill Combo Console for Rhinoplasty & Facial Surgery; Elevaris Launches CDMO Services and Procedural Needle Offerings in EMEA; Cardinal Health Successfully Acquired Solaris Health; 4WEB Medical Sets a New Standard in Implant-Based Therapy; BD Reaches Key Milestone in AGILITY Trial Evaluating Revello™ Vascular Covered Stent for PAD

pharma-news-for-ucb-brainxell-metsera

Intensity Therapeutics Publishes Compelling Clinical Data for INT230-6 in Advanced Cancers; UCB Wins FDA Approval for KYGEVVI for Rare Mitochondrial Disease TK2d; BrainXell Therapeutics Unveils Promising Preclinical Data for iPSC-Derived Neuronal Therapy in Parkinson’s Disease; CARsgen Therapeutics Reports Encouraging Clinical Data for Allogeneic CAR-T Products in Hematologic Malignancies; Novo Nordisk’s $9 Billion Counterbid for Metsera Ignites Landmark Obesity Drug Market Battle

medtech-news-for-zimmer-biomet-medtronic-laborie

Zimmer Biomet Wins FDA Breakthrough Status for Iodine-Treated Hip Implant; Terumo Gains U.S. Clearance for OPUSWAVE® System and DualView® Catheter; Medtronic’s Symplicity Spyral RDN Device Added to CMS National Coverage; West Launches Synchrony™ PFS System at CPHI; Emboline Completes U.S. Pivotal IDE Trial Enrollment for Emboliner® Device; Laborie Completes First Procedures in ENDURE 1 Trial with Optilume® Balloon

pharma-news-for-novartis-gsk-syndax

Syndax Pharmaceuticals Receives FDA Approval for REVUFORJ; FDA Approves BLENREP for Adults with Relapsed/Refractory Multiple Myeloma; Novartis to Acquire Avidity for $12 Billion; BridgeBio Reports Positive Phase 3 Results for Small Molecule BBP-418 in LGMD2I/R9 FORTIFY Study; Eli Lilly to Acquire Adverum Biotechnologies

medtech-news-for-oncohost-bd-oticon

OncoHost Granted New York State Lab Permit, Enabling PROphetNSCLC® Nationwide Access; Onkos Surgical’s ELEOS Proximal Tibia with NanoCept antibacterial surface receives FDA 510(k) clearance; BD’s Simplified At-Home HPV Test to Expand Cervical Cancer Screening Internationally; Oticon’s New Zeal™ Hearing Aid Delivers Discreet Style with Next-Gen AI Sound & Connectivity; Nyra Medical Launches First­-in-Human Trial of New Mitral Valve Repair System; Cordis Reveals 12-Month Outcomes from SELUTION SLR DEB Trial

pharma-news-for-roche-astrazeneca-replimune

FDA Approves Genentech’s GAZYVA for Lupus Nephritis; Glaukos’ EPIOXA Wins FDA Approval for Keratoconus Treatment; FDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma; Cogent’s Bezuclastinib Earns FDA Breakthrough Therapy for SM-AHN; Amgen’s TEZSPIRE Gets FDA Nod for Chronic Rhinosinusitis with Nasal Polyps

medtech-news-for-scanogen-lapsi-health-medtronic

Scanogen’s Bloodstream Infection Assay Earns FDA Breakthrough Device Status; Lapsi Health Launches Keikku 2.0; Medtronic BrainSense™ Adaptive DBS Earns 2025 TIME Best Inventions Honor; Photocure Partners with Intelligent Scopes Corporation to Advance AI Integration in Blue Light Cystoscopy; Conformal Medical Expands CONFORM Trial to Europe; Materna Medical Presents Study on At-Home Patient Outcomes: Experienced vs. Naïve Dilator Users

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