Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Powerful Medical’s AI ECG Technology Earns FDA De Novo Authorization for Heart Attack Detection; Werfen Secures US FDA 510(k) Clearance and CE Mark for Aptiva® APS IgA Reagent; Ontario Introduces Fetal Blood Type Screening to Improve Pregnancy Care; Medvue Concorde Acquires Next-Generation AI-Powered MRI System; Cardiol Therapeutics Hits Phase III MAVERIC Enrollment Target Early and Expands Pivotal Trial for CardiolRx; Ferronova Reports Preliminary MAGMAP Results in 62-Patient Gastric and Oesophageal Cancer Trial

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pharma-news-for-novo-telix-beacon

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

medtech-news-for-emboline-powerful-medical-zeiss

Ferronova Announces Preliminary MAGMAP Results in 62-Patient Gastric and Oesophageal Cancer Trial; Powerful Medical Secures FDA De Novo Authorization for AI ECG Model; ZEISS Advances Cataract Surgery with Introduction of AT LUCIA toric 721P; Waters Launches BD FACSDiscover A7 Cell Analyzer for Standardized Spectral Flow Cytometry; Nicklaus Children’s Hospital Completes One of the Country’s First Transcatheter Fontan Procedures in a Two-Year-Old

pharma-news-for-astrazeneca-scholar-rock-pharming

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-emboline-alcon-avo

Emboline Secures FDA 510(k) Clearance for Emboliner® Embolic Protection System; Alcon’s Clareon Monofocal IOL Secures EU MDR Certification from TÜV SÜD; Shoulder Innovations Enters Exclusive Partnership with ALM Ortho for Complex Shoulder Reconstruction Solutions; Avo Expands MEDITECH Alliance, Bringing Full Suite of AI Solutions to EHR; Nicklaus Children’s Hospital Performs Pioneering Transcatheter Fontan Completion in Two-Year-Old Child; AEYE Health Publishes AEYE-DS Clinical Trial Results Demonstrating High Diagnostic Accuracy and >99% Imageability

pharma-news-for-novo-clover-novartis

Novo Nordisk’s STEP Young Phase 3 Results Highlight Semaglutide’s Potential in Pediatric Obesity; Clover Reports Positive Phase 2 Clinical Findings for RSV + hMPV ± PIV3 Vaccine Candidates; Novartis Reveals Topline Results From Phase III Lp(a)HORIZON Trial of Pelacarsen; US Approves Etcamah Plus CDK4/6 Inhibitor for 1st-Line Advanced HR-Positive Breast Cancer; ZANVASTRO Wins FDA Approval as a First-of-Its-Kind Disease-Modifying Treatment for Alexander Disease

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

pharma-news-for-takeda-eil-lilly-teva

Takeda’s MIMRYLO Wins U.S. FDA Approval for Polycythemia Vera; Lilly’s Mounjaro Gains FDA Approval for Cardiovascular Risk Reduction in Type 2 Diabetes; Teva Expands Neuroscience Portfolio Through Proposed Acquisition; BioNTech Ends Phase 2 Study of Autogene Cevumeran in Colorectal Cancer; AusperBio Secures $120 Million Series C to Advance AHB-137 and Next-Generation Hepatitis B Therapies

medtech-news-for-spineart-ecential-robotics-zeiss

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

pharma-news-for-gsk-amylyx-ultragenyx

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

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

pharma-news-for-astrazeneca-argenx-bristol-myers-squibb

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

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

medtech-news-for-rongtao-medical-nipro-lyric-health

Rongtao Medical Receives Prestigious Bonded Repair Authorization for Ultrasound in China; NIPRO Introduces ELISIO™-HX Expanded Hemodialysis System to U.S. Market Following FDA Clearance; Lyric Health Unveils Asynchronous Care Solution for Smarter, Connected Virtual Care; New England Biolab® Strengthens Cell-Free RNA Workflow with Monarch® Mag Cell-free RNA Extraction Kit; Aqua Medical Advances Type 2 Diabetes Research with First U.S. Patient Treated at UNC Health; MediView XR90™ Holographic Surgical Navigation System Debuts in Florida at Cleveland Clinic Weston Hospital

pharma-news-for-astrazeneca-novartis-abbvie

EU Approves Datroway for First-Line Metastatic TNBC; FDA Broadens Pluvicto’s Reach with Approval in PSMA+ mHSPC; AbbVie Announces EU Authorization of RINVOQ for Severe Alopecia Areata; Novo Nordisk Announces Latest Developments from the ZEUS Phase III Trial; Replimune Secures Positive FDA Advisory Committee Vote for RP1 in Advanced Melanoma

medtech-news-for-nipro-akido-aqua-medical

SIO Urges NCCN to Add Cryoablation to Breast Cancer Guidelines Following ProSense® FDA Clearance; NIPRO CORPORATION Secures FDA 510(k) Clearance for ELISIO™-HX HDs in the US; Akido Unveils the First AI-Native Health System in the U.S.; MemorialCare Enhances Diagnostic Imaging with Hung Family-Funded 3T MRI Technology; Aqua Medical Treats First U.S. Type 2 Diabetes Patient at UNC Health with Investigational Endoscopic Therapy; NeoCast Delivers Robust Hematoma Resolution and Functional Recovery in Final EMBO-02 First-in-Human Results

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