Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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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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

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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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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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Seegene USA Advances Infectious Disease Diagnostics with FDA EUA for Multiplex PCR Assay; Synergy Disc® Achieves 100 U.S. Cases Within 100 Days of FDA Approval; Moon Surgical and KARL STORZ Forge Strategic Commercial Alliance to Expand Scalable Surgery; Cepheid to Showcase Third-Generation GeneXpert® System at ADLM 2026; Co-Diagnostics and CoSara Launch Clinical Studies in India for PCR-Based Tuberculosis Test; NeoCast Delivers Strong Clinical Outcomes in Chronic Subdural Hematoma in Final First-in-Human EMBO-02 Study

pharma-news-for-novartis-gsk-merck

Novartis Secures FDA Traditional Approval for Fabhalta in Primary IgAN; GSK Reports Mixed Phase III Results for Camlipixant in Refractory Chronic Cough; Merck Secures FDA Approval for LIPFENDRA; Innovent Reports Positive Phase II Results for Soficinib in Vitiligo; Lilly Signs Deal to Acquire AtaiBeckley for Mental Health Therapies

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POLYTECH Announced Regulatory Clearance for Improvements to the Microthane Process; ElectroWire Medical Earns 510(k) Clearance for LightningWire™ System; NeuroLexIQ Partners with Canary Speech to Introduce AI-Driven Voice Analysis for Injury Intake; BIOTRONIK Neuro Acquires Spinal Cord Stimulation Technology from Soin Neuroscience; Lakewood-Amedex Biotherapeutics Highlights Preclinical Safety Evidence Ahead of Nu-3 Gel Phase 2a Study; Cumulus Neuroscience Presents Evidence That Two-Minute Digital Test Enhances Alzheimer’s Trial Pre-enrichment

pharma-news-for-hengrui-kailera-gsk

Hengrui Pharma Encounters FDA Regulatory Hurdle for Camrelizumab–Rivoceranib; Kailera Therapeutics Announces Positive Results for HRS-7535/KAI-7535 Across Two Phase 3 Studies; Jemperli Underscores Durable Clinical Complete Responses in dMMR/MSI-H Rectal Cancer; FDA Approves PADCEV-Keytruda Combination for Neoadjuvant and Adjuvant Treatment of Muscle-Invasive Bladder Cancer; Sanofi’s Subcutaneous Sarclisa Escena Gains US Approval

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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

pharma-news-for-novartis-roche-otsuka

Novartis to Acquire Myricx Bio; Roche’s Divarasib Tops Approved KRAS G12C Inhibitors in Phase III NSCLC Trial; Otsuka Reports Positive Two-Year Phase 3 Results for VOYXACT in IgA Nephropathy; Revolution Medicines Reports Early Clinical Data for Zoldonrasib Combination Regimens at ESMO GI 2026; Can-Fite Completes Patient Enrolment for Interim Analysis in Pivotal Phase 3 Psoriasis Trial

medtech-news-for-starmed-scibase-alr-technologies

STARMED Secures FDA 510(k) Clearance for Benign Thyroid Nodule Ablation; SciBase Advances U.S. Expansion with FDA 510(k) Submission for Nevisense; ALR Technologies to Acquire CGM Medical Technology in US$45 Million and 200 Million Share Deal; Co-Diagnostics Completes Validation Studies Ahead of FDA 510(k) Submission for Upper Respiratory Point-of-Care Test; Corvention Launches Innovative Balloon Catheter in the U.S. Following First Clinical Case; OrthAlign Reports First Clinical Cases Using Lantern® ASC System

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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

Legacy Expands Diagnostic Portfolio with New York CLEP Approval for Two LDTs; Quest Diagnostics Expands Patient Access to ctDNA MRD Testing with New York Approval of Haystack MRD; MVZ MedDiagnost and Sectra Ink 10-Year Deal to Unify Radiology Network Across 10 Sites; ALZpath and Abbott Enter Global Licensing Deal to Expand Blood-Based Alzheimer’s Diagnostics; Corvention Reaches Key Commercial Milestone with First U.S. Procedure and Balloon Catheter Launch; ZETA SURGICAL® Achieves First Clinical Milestone with Initial Patient Treatment at HOPE Therapeutics

pharma-news-assessment-for-definium-abbvie-apogee

Definium Reports Positive Phase 3 EMERGE Results for DT120 ODT in MDD; AbbVie to Buy Apogee Therapeutics; TrueLab Announces Strategic Antibody Licensing Collaboration with Bionyra Pharma; Nura Bio Secures Series B Financing to Advance SARM1 Programs; Moderna’s mRNA-1010 Earns Unanimous FDA Advisory Committee Backing on Benefit-Risk Profile

medtech-news-for-fibersense-amdi-icarus-medical

FiberSense CGM System Secures CE Mark; AMDI™ Fast PCR System Achieves FDA 510(k) Clearance and CLIA Waiver for Near-Patient Respiratory Diagnostics; Icarus Medical Raises $7.2 Million Series A to Drive Next-Phase Growth; Crescom and Mass General Brigham Launch Global Proof of Concept for Pediatric Musculoskeletal AI; VahatiCor Reaches Key Milestone with First U.S. Patient Dosed in SERRA-I CMD Study; Sonex Health Unveils Results From Largest-Ever U.S. Investigation of UltraGuideCTR™

medtech-news-updates

Sibel Health Secures EU MDR CE Mark, Subtle Medical Wins FDA Clearance, Roche Acquires PathAI, Carestream Launches Lux HD Detectors, and New Clinical Milestones in Atopic Dermatitis & Carpal Tunnel Care

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