Ophthalmology

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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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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

pharma-news-for-astrazeneca-argenx-otsuka

Ultomiris Phase III Trial Update Highlights Progress in Post-Transplant TMA; argenx Acquires Forte Biosciences; Otsuka’s SIMTRIYO Receives FDA Nod as a First-in-Class ADHD Treatment; Outlook Therapeutics Secures FDA Approval for LYTENAVA to Treat Wet AMD; Merck Reveals Future Access Strategy for Once-Monthly Oral HIV Prevention Therapy Alimatravir

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Zymeworks Announces Acquisition of Theravance Biopharma; Ipsen to Acquire Kartos Therapeutics; Viridian Therapeutics Wins U.S. FDA Approval for Lumvoa; Replimune Reaches FDA Milestone with RP1 BLA Resubmission Acceptance; Epicrispr Announces Encouraging Clinical Data for EPI-321 in FSHD

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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

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Unlocking Growth Potential in the Presbyopia Treatment Market: Innovations Reshaping Age-Related Vision Loss

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Restore Robotics Secures FDA 510(k) Clearance for Two New da Vinci Xi® Instruments; Medtronic Wins FDA Approval for OmniaSecure™ Defibrillation Lead Enabling Conduction System Pacing; Bebird Introduces EarSight Ultra; BD Introduces AI-Driven Medication Dispensing System in Europe; i-Lumen Scientific Secures FDA IDE Approval to Launch U.S. Enrollment for i-SIGHT2 Dry AMD Trial; Belay Diagnostics Highlights 82% Clinical Impact Rate in CNS Lymphoma Evaluation

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Top 8 Breakthrough Gene Therapies for Retinitis Pigmentosa Treatment

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LiviWell Receives FDA Clearance for Livi, Pioneering Post-Intercourse Vaginal Care; Medtronic Advances Spine and Cardiac Care with ViaVerte Partnership and FDA Approval of OmniaSecure Lead; ZEISS Broadens Its Ophthalmic Workflow Portfolio in Canada; Starlight Cardiovascular Reports First-Ever Infant Treated with Lifeline Stent System at Cincinnati Children’s Hospital; Belay Diagnostics Highlights 82% Clinical Impact Rate for Summit™ and Vantage™ in CNS Lymphoma

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Sana Biotechnology Reveals Long-Term Positive Data from Type 1 Diabetes Islet Cell Transplant Trial; Bayer’s Finerenone Demonstrates Efficacy in Phase III FIND-CKD Study in Non-Diabetic CKD Population; Immutep Halts Phase III NSCLC Trial; REGENXBIO’s RGX-202 Demonstrates Promising Interim Results in Phase I/II AFFINITY DUCHENNE Trial; Ultragenyx’s DTX301 Gene Therapy Delivers Positive 36-Week Phase 3 Data

pharma-news-for-pilatus-astrazeneca-sanofi

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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Biologics and The Battle For Sight: How A New Wave of Therapies is Transforming Graves’ Orbitopathy Treatment

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-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

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The Rise of AI-Powered Point-of-Care Diagnostics: Transforming Real-Time Patient Care

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The Race for Next-generation Wet AMD Therapies: Shaping the Future of Vision

medtech-news-for-geneseeq-technology-medtronic-corneat-vision

Geneseeq Technology Inc.’s GENESEEQPRIME® Assay Receives FDA 510(k) Clearance; Medtronic’s MiniMed™ 780G Gains FDA Approval for Abbott Instinct Sensor Integration and Type 2 Diabetes Use; CorNeat Vision’s Artificial Cornea Restores 20/20 Vision for Shingles-Induced Blindness; Johnson & Johnson Reports Favorable Outcomes from Real-World VARIPULSE™ PFA Study at 2025 ESC Congress; SprintRay Strengthens Dental 3D Printing Portfolio with EnvisionTEC Acquisition; Olympus Unveils Latest Imaging Platform for ENT and Urology in the U.S.

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