Oncology

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

ProBio Announces Completion of NMPA Pre-Approval Inspection at Its China Manufacturing Facility; Providence Medical Secures FDA Approval for CORUS PCSS 3D-T Spinal Device; Sony Semiconductor Solutions Launches Compact Image Sensor for Single-Use Endoscopes; Ping An Launches China’s First Comprehensive Alzheimer’s Disease Brain Health Management Program; Geneos Therapeutics Advances Personalized DNA Immunotherapy for Liver Cancer into Phase 2; Medtronic Reports Positive Real-World Data for Sphere-9 and PulseSelect PFA

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Osteosarcoma Treatment Landscape: Can New Therapies Break a 40-Year Stalemate in Bone Cancer Care?

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FGFR Inhibitors: How a Once-Overlooked Target Became Precision Oncology’s Next Big Story

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UTR Therapeutics’ UTRxMYCN M1-14 Granted FDA Orphan Drug and Rare Pediatric Disease Designations; Medtronic Announces Regulatory Milestones for New Cardiac Mapping and Ablation Software; Abbott Adds SimpleScreen™ CRC Blood Test to Colorectal Cancer Screening Portfolio; VEMERIX Introduces Patented Single-Use Ultrasound Puncture Kit With Customized Probe Compatibility; Avisi Technologies to Showcase Two-Year VisiPlate® Results at AAO Annual Meeting; FIRE1 Implants First Patient in NORM-HF Pivotal Trial for Innovative Heart Failure Management

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Novo’s CagriSema Shows Greater Weight Loss Than Tirzepatide in REIMAGINE 5 Trial; Telix and ITM Partner to Build a Radiopharmaceutical Powerhouse; Beacon Therapeutics Reveals Positive Topline Findings from VISTA Trial of Laru-zova for XLRP; FDA Clears Inluriyo in Combination with Verzenio for Adults with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer; IntraBio Announces FDA Approval of AQNEURSA for Ataxia-Telangiectasia

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TAGRISSO Delivers Landmark Eight-Year Survival Outcomes in Early-Stage EGFR-Mutated Lung Cancer; Scholar Rock Receives FDA Approval for ISEMBYLD; Pharming’s Joenja Receives FDA Approval as First U.S. Treatment for Children With APDS; AbbVie Reports Positive Phase 3 Results for Atogepant in Menstrual Migraine; Rezera’s Ruvonoflast Delivers Positive Inflammation Results with Favorable Safety in RESOLVE-1

medtech-news-for-alcon-btl-stryker

Spineart’s PERLA® TL Application Receives FDA 510(k) Clearance for eCential Robotics’ Op.n® Platform; Alcon’s Clareon Monofocal IOL Earns EU MDR Certification; BTL Expands Into Laser Technology With New Division and EXOLASE ONE; Stryker, IAGE Collaborate to Enhance Fluorescence-Guided Surgery Training in India; Galmed Announces Positive First-in-Human Results for Colospan’s Novel Tissue Assessment Platform; FastWave Medical Secures FDA IDE Approval for Pivotal Artero Peripheral IVL Trial

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The Next Wave in Peripheral T-Cell Lymphoma Treatment: 4 Late-Stage Drugs Making Their Mark

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Spineart and eCential Robotics Gain FDA Clearance for PERLA® TL Robotic Surgery Application; ZEISS CLINIC 360 Earns FDA 510(k) Clearance, Strengthening Data-Driven Patient Care; Bittium Introduces Faros Pro™ and EasyFlex™ for Extended Ambulatory ECG Monitoring; Cytrellis Expands ellacor® Micro-Coring® Technology to Australia for Full-Body Skin Resurfacing; Galmed Announces Successful First-in-Human Study of Colospan’s Novel Tissue Assessment Technology; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial

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US FDA Grants Priority Review to Jemperli for dMMR/MSI-H Locally Advanced Rectal Cancer; Amylyx’s Avexitide Achieves Positive Topline Results in Phase 3 LUCIDITY Study; Ultragenyx Marks Major Milestone as FDA Approves GENGLYCOS for GSDIa; Pasatru Receives FDA Approval for Fibrodysplasia Ossificans Progressiva; Merck and Moderna’s Intismeran Autogene Plus KEYTRUDA Delivers Positive Phase 3 Results in Resected Melanoma

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BMS Claims the First CELMoD Crown as ZENBEXUS Raises the Stakes in Multiple Myeloma Treatment

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T-Cell Malignancies: The Evolving Treatment Landscape and the Race for Market Leadership

medtech-news-for-empatica-colospan-biolab-holdings

Empatica Secures FDA Clearance for Parkinson’s Monitoring; ZEISS CLINIC 360 Secures FDA 510(k) Clearance; BioLab Holdings Strengthens Tissue Restoration Portfolio With Addition of FastSkin® Technology; Surity™ Expands Urinary Incontinence Care Portfolio with New At-Home Urinary Management System; Galmed Announces Positive First-in-Human Proof-of-Concept Results for Colospan’s Intraoperative Tissue Assessment Platform; FastWave Medical Secures FDA IDE Approval for Pivotal Artero™ Peripheral IVL Trial

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AstraZeneca Discontinues Phase III eVOLVE-Lung02 Trial of Volrustomig in Metastatic NSCLC; argenx Announces Favorable Topline Results from Phase 3 ALKIVIA Study of Efgartigimod; Bristol Myers Squibb’s ZENBEXUS Receives U.S. FDA Accelerated Approval in Combination with Daratumumab and Dexamethasone for Multiple Myeloma; Zealand Pharma Secures USD 100 Million in Royalty Financing Through Agreement with Royalty Pharma for Rusfertide; PTC Advances Rare Disease Strategy with Acquisition of ST-920 Fabry Disease Program

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Replimune Strengthens Oncology Portfolio With TUDRIQEV Approval

Leica Biosystems Expands Digital Pathology Portfolio with Multiple FDA Clearances; Bracco’s VueJect Ultrasound Contrast Delivery System Gains FDA and Health Canada Authorizations; Oticon Introduces Next-Generation Reveal Hearing Aid With AI; Zepto Life Technology Secures Up to $8.9 Million NIAID Award for Infectious Disease Liquid Biopsy Platform; Nitinotes Broadens EASE IDE Trial Network for EndoZip; FastWave Medical Secures FDA IDE Approval for Pivotal Artero Peripheral IVL Trial

pharma-news-for-sobi-transthera-sciences-replimune

Sobi Partners with Innate Pharma to License Lacutamab for T-Cell Lymphoma; Yochanra Makes Global Debut in China as First Innovative Drug Designed to Overcome FGFR Inhibitor Resistance; Replimune Secures FDA Accelerated Approval for TUDRIQEV Plus Nivolumab in Advanced Cutaneous Melanoma; FDA Accepts Supplemental Biologics License Application for ENFLONSIA to Broaden RSV Indication in Young Children; Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals

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