Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Presage Technologies Unveils Free Access to FDA-Cleared Contactless Vital Signs Technology; CliniComp Secures FDA Clearance for MIMPS PACS Viewer with Unified Imaging and AI Capabilities; Advita Ortho Strengthens the Scientific Foundation for Predictive Planning in Total Knee Arthroplasty; RunStar® Expands Health Device Portfolio with New Smart Blood Pressure Monitor; Nyra Medical Initiates ENHANCE Early Feasibility Study with First Patient Enrollment; Penumbra Enrolls First Patient in FORWARD Study for Distal Acute Ischemic Stroke

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pharma-news-for-roche-incyte-tango

Roche Expands Pipeline Through Global Bexobrutideg Partnership with Nurix Therapeutics; Incyte to Acquire Vega Therapeutics; Tango Therapeutics Unveils Promising Pancreatic Cancer Data with Vopimetostat–Daraxonrasib Combination; Otsuka Announces Encouraging 12-Month eGFR Outcomes from Phase 3 VISIONARY Study of VOYXACT in IgAN; Innovent Biologics Unveils Phase 3 DREAMS-3 Findings for First Approved GCG/GLP-1 Dual Receptor Agonist

medtech-news-and-updates

OrthAlign FDA Clearance for Lantern ASC System, Zepto Life FDA Breakthrough Designation, Precision Spine Launch, Leica Biosystems AI Expansion, ShiraTronics Trial Milestone & Implantica GERD Cost-Effectiveness Study Drive Major MedTech Innovation Advances

pharma-news-for-hanmi-eli-lilly-pfizer

Hanmi Pharmaceutical and Eli Lilly and Company Join Forces to Advance Sonefpeglutide Development; Johnson & Johnson’s ERLEADA Achieves Positive Phase 3 Outcomes; Revolution Medicines Unveils Landmark Phase 3 RASolute 302 Data Demonstrating Strong Efficacy of Daraxonrasib in Metastatic Pancreatic Cancer; Pfizer’s BRAFTOVI Treatment Advances Outcomes by Nearly Doubling Progression-Free Survival in mCRC; Imfinzi Sets a New Standard with US Approval of the Only Immunotherapy Combination for BCG-Naïve High-Risk Bladder Cancer

medtech-news-for-toby-subtle-medical-ernest-health

FDA Grants Breakthrough Device Status to TOBY’s Urine Test for Alzheimer’s Detection; ubtle Medical Achieves FDA Clearance for Next-Gen SubtleHD™(PET) Software; Ernest Health Expands Rehabilitation Network Through Reunion Hospitals Deal; Olympus Expands Prostate Cancer Footprint Through BioProtect Acquisition; ABILITY Neurotech Secures IMDD Approval for Clinical Trial of Chronic Brain-Computer Interface Implantation in ALS Patients; Implantica Reports Strong Economic Benefits of RefluxStop® in Italian GERD Treatment Study

pharma-news-for-astrazeneca-gilead-biogen

US Greenlight for Datroway Marks First TROP2 ADC Approval in Frontline mTNBC Beyond PD-1/PD-L1 Candidates; Gilead’s Hepcludex Achieves Historic FDA Approval Milestone in Chronic HDV; Biogen and Denali Therapeutics Report Progress in Phase 2b Evaluation of BIIB122 for Parkinson’s Disease; Eli Lilly and Company Spotlights Foundayo’s Late-Stage Success in Obesity Studies; BioMarin Shares Successful Phase 3 Study Outcomes for VOXZOGO® in Children with Hypochondroplasia

medtech-news-for-trilliumbio-oncobit-advita-ortho

Leo Cancer Care Receives CE Mark Approval for Marie® Upright Radiotherapy System;  PorTal Access, Inc. Hits Critical Regulatory Benchmark with Flexi-Port™ 510(k) Submission; Araceli Biosciences Introduces Endeavor® Live Cell to Accelerate AI-Driven Drug Discovery Imaging; TrilliumBiO Partners with Oncobit to Launch Next-Generation Uveal Melanoma Monitoring Platform; Advita Ortho Reports First Clinical Application of Equinoxe® Scapula Reconstruction System; Implantica Announces Findings Supporting RefluxStop®’s Economic Advantage in GERD Treatment in Italy

pharma-news-for-astrazeneca-regeneron-daiichi-sankyo

BAXFENDY Receives US Approval for Adult Hypertension as a First-in-Class Aldosterone Synthase Inhibitor; Regeneron Pharmaceuticals Shares New Developments in Phase 3 Melanoma Study of Fianlimab Combination; ENHERTU Gains Two New US Indications in HER2-positive Early Breast Cancer; REGENXBIO Reveals Positive Pivotal Trial Results for Duchenne Gene Therapy RGX-202; BeOne Medicines Gains FDA Approval for BEQALZI™ in R/R Mantle Cell Lymphoma

medtech-news-for-aurie-biozen-plusone

Aurie Wins FDA De Novo Grant for Innovative Reusable Urinary Catheter Technology; Biozen Secures FDA Clearance for Calibration-Free Cuffless Blood Pressure Technology; plusOne® Expands Wellness Care Portfolio with New Menopause and Fertility-Friendly Lubricants; TrilliumBiO and Oncobit Introduce Advanced Uveal Melanoma Monitoring Solution in the U.S.; Renerva Announces First-in-Human Implant of PNM-CAP™ for Neuroma Pain; SonoClear AS Announces Completion of Clinical Enrollment for Breakthrough Device-Designated SonoClear® System

pharma-news-for-gsk-artiva-biogen

GSK Signs Exclusive Collaboration with SBP Group to Strengthen Commercialization of Bepirovirsen in China; Artiva Announces Strong Early AlloNK® Results and FDA Alignment for Pivotal Rheumatoid Arthritis Trial in 2026; FDA Reviews LEQEMBI IQLIK Subcutaneous Starting Dose Under Priority Review Pathway; ParcelBio Announces Programmable mRNA Platform Amid $13M Capital Infusion; Entrada Therapeutics Reports Promising Topline Efficacy and Safety Results for ENTR-601-44 in Duchenne Muscular Dystrophy

medtech-news-for-multi4-medical-ortho-development

Multi4 Medical Gains CE Mark Approval for Office-Based Bladder Cancer Treatment; FX Shoulder Solutions Achieves FDA 510(k) Clearance for FX V135® Easytech Platform; Ortho Development Launches Commercial Rollout of Trivicta® Hip Stem; Clover Podiatry Expands Foot and Wound Care Services With New Advanced Healing Center; CLiMB Study Highlights Superior Sensitivity of HelioLiver™ Blood Test Versus Ultrasound in Detecting Early-Stage HCC; Aqua Medical Unveils Promising DDW 2026 Data Showing Sustained Insulin Elimination in Type 2 Diabetes Patients

pharma-news-for-ucb-pfizer-axsome

UCB to Acquire Candid Therapeutics; Pfizer’s ELREXFIO Sets New Benchmark in PFS for Hard-to-Treat Multiple Myeloma Patients; Axsome Therapeutics Wins FDA Approval for AUVELITY to Address Alzheimer’s Agitation; FDA Advisory Panel Backs Truqap for PTEN-Deficient mHSPC; Bepirovirsen Receives FDA Priority Review Alongside Breakthrough Therapy Tag

medtech-news-for-olympus-abbott-bd

Olympus Secures FDA Clearance for POWERSEAL™ Open Extended Jaw Device; Abbott’s Ultreon™ 3.0 Receives FDA Clearance and CE Certification; LTS Broadens CDMO Capabilities with Ophthalmic Drug Delivery Expertise; BD Transforms Central Line Placement with Groundbreaking Technology; AI Models Deliver Up to 73% Fewer Genome Analysis Errors in New Research; Calidar Finishes Enrollment in First-in-Human Trial of 4D Mammography System

pharma-news-for-eli-lilly-sun-pharma-novartis

Eli Lilly and Company to Acquire Ajax Therapeutics; Sun Pharma Moves to Acquire Organon in Definitive Agreement; European Commission Approves Novartis RHAPSIDO as First Oral Targeted Therapy for Chronic Spontaneous Urticaria; Tovecimig Delivers Significant Clinical Benefit in COMPANION-002 Phase 2/3 Trial for Biliary Tract Cancer; Arrowhead Pharmaceuticals Receives CHMP Backing for REDEMPLO Approval in Europe for Familial Chylomicronemia Syndrome

medtech-news-for-utepreava-sonorous-neurovascular-organabio

Utepreva Announces FDA 510(k) Clearance for Endometrial Sampler Aimed at Early Cancer Detection; Sonorous Neurovascular Announces FDA 510(k) Clearance of BosCATH Neurovascular Catheter; OrganaBio and RxMP Therapeutics Partner to Support Manufacturing of RMP-402 Hemostatic Therapy; RhythMedix Introduces the New RhythmStar® SL Advanced Cardiac Monitor; Nicklaus Children’s Hospital Achieves First Traveling Bedside PDA Closure in Fort Lauderdale NICU; RIVANNA Advances Multi-center Clinical Study of Accuro XV Musculoskeletal Imaging System

pharma-news-for-novo-ucb-merck

Novo Nordisk Reports Positive Phase 3 Results for Etavopivat in Sickle Cell Disease; UCB to Buy Neurona Therapeutics; KEYTRUDA Regimens Secure FDA Priority Review in Muscle-Invasive Bladder Cancer; Savara Announces FDA Review Extension for Molgramostim in Autoimmune PAP; Terremoto Biosciences Completes $108 Million Series C Financing to Expand AKT1 Inhibitor Development

medtech-news-for-reach-surgical-toby-dupont

Reach Surgical Announces CE Mark Certification for Innovative iREACH IRIS Stapling System; TOBY Earns FDA Breakthrough Tag for Innovative Urine-Based Cancer Detection Test; DuPont Introduces AmberChrom™ XT SL Resins to Streamline Biopharma Processing; Sectra Strengthens AI Roadmap with Completion of Oxipit Acquisition; KingstronBio Marks First Patient Implant of ProStyle M® in National Multicenter Study; MiRus Starts Recruiting Patients for STAR Trial Evaluating Siegel™ Valve

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