Notizia - Recent Pharma, Healthcare and Biotech Happenings

medtech-news-for-gore-stereotaxis-stimlabs

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Gore Secures FDA Approval for Its First Deep Venous Stent for IVC and Iliofemoral Veins; Stereotaxis Secures FDA Approval for MAGiC Ablation Catheter; Stimlabs® LLC Announces FDA 510(k) Clearance and Launch of Allacor P™ for Wound Care; CorePlus and AIxMED Join Forces to Deliver AI-Powered Bladder Cancer Detection with Complete QC; Interim Clinical Outcomes at Six Months from the SPARTAN Study Evaluating the TransLoc 3D™ System; TYBR Health Reports First U.S. Clinical Use of the B3 GEL™ System

Explore More...
pharma-news-for-zenas-sanofi-axsome

Zenas BioPharma’s Obexelimab Delivers Positive Phase 3 Results in IgG4-RD; Sanofi Secures US Priority Review for Tzield in Pediatric Stage 2 Type 1 Diabetes; Axsome’s AXS-05 sNDA Accepted by FDA with Priority Review for Alzheimer’s Agitation; Vanda’s NEREUS Receives FDA Approval; Omeros’ YARTEMLEA Sets Milestone as First Approved TA-TMA Therapy

medtech-news-for-edwards-lifesciences-stimlabs-ngd-infection-prevention

Edwards Lifesciences Receives FDA Approval for SAPIEN M3 Mitral Valve System; StimLabs Secures FDA Clearance for Theracor™, an Umbilical Cord–Derived Medical Device Sheet; NGD Infection Prevention Installs NGD200 System at the Middle East’s Largest Medical Center; Overture Orthopaedics Reaches $1.0M Sales Milestone for OvertureTi® Knee Resurfacing System; Envoy Medical Achieves Enrollment Milestone in Pivotal Trial of Fully Implanted Acclaim® Cochlear Implant; Galaxy Therapeutics Announces Completion of Patient Enrollment in Pivotal SEAL-IT IDE Trial

pharma-news-for-novo-windward-astrazeneca

Novo Nordisk Gains US Approval for Oral WEGOVY; Windward Bio Strengthens Immunology Pipeline With Clinical-Stage Bispecific WIN027; US FDA Grants Breakthrough Therapy Designation to ENHERTU in the Post-neoadjuvant Setting for HER2-positive Early Breast Cancer; Ipsen Enhances Early R&D Pipeline via Simcere Zaiming ADC; Roche Secures FDA Approval for SC Lunsumio VELO in Follicular Lymphoma

medtech-news-for-abbott-medicus-solventum

Johnson & Johnson Secures FDA Approval for TRUFILL® n-BCA in Chronic Subdural Hematoma Treatment; Abbott’s Volt™ Pulsed Field Ablation System Gains FDA Approval for AF Patients; Medicus Pharma Ltd. Partners with Reliant AI to Develop an Artificial Intelligence–Driven Clinical Data Analytics Platform; Solventum Finalized the Acquisition of Acera Surgical; Envoy Medical Hits Critical Enrollment Benchmark in Acclaim® Cochlear Implant Pivotal Trial; Galaxy Therapeutics Completes Enrollment in Pivotal SEAL IT IDE Study

pharma-news-for-novo-astrazeneca-cytokinetics

Novo Nordisk Seeks FDA Approval for CagriSema; EU Approves Subcutaneous Self-administration of SAPHNELO via Pre-filled Pen for SLE; Cytokinetics Secures FDA Approval of MYQORZO for Adult Patients with Symptomatic Obstructive HCM; Boehringer’s JASCAYD Wins FDA Approval for Adult Pulmonary Fibrosis; BioMarin to Acquire Amicus for $4.8B, Advancing Long-Term Growth in Rare Diseases

medtech-news-for-bd-orthalign-bioretec

BD Broadens BD MAX™ System Menu with IVDR-Certified VIASURE Assays; OrthAlign Broadens the Lantern® Hip Platform for Posterior Approach Total Hip Arthroplasty; Bioretec Received FDA Breakthrough Device Designation for the Remeos™ Drillpin; Medivis Achieves First FDA Authorization for AR Navigation in Neurosurgery; Cerapedics Publishes 24-Month ASPIRE Clinical Outcomes in Spine Journal; Acumed’s Acu-Loc NEXT System Debuts in First Wrist Fixation Surgery at Duke University Hospital

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

medtech-news-for-bendit-proverum-medint

Bendit Received FDA Clearance for the Bendit17™ Steerable Microcatheter; ProVee System Receives FDA Approval as a New-Era Prostatic Urethral Stent for BPH; a2z Radiology AI Secures $4.5M Seed Funding to Advance Full-Spectrum CT Analysis; MedINT Introduces Advanced Medical AI System Integrating Clinician Oversight; Nitinotes Treats First Patient in Pivotal EASE™ Trial of the EndoZip™ Automated Suturing System for ESG; Airiver Medical Secures FDA IDE Authorization to Launch Pivotal CRS Clinical Trial

pharma-news-for-kallyope-ideaya-ayrmid

Kallyope’s Elismetrep Achieves Primary and Secondary Endpoints in Phase 2b Clinical Study; IDEAYA Secures IND Approval to Initiate Clinical Evaluation of IDE034; OMISIRGE Receives FDA Approval; Agios Updates on Regulatory Path for Mitapivat to Treat Thalassemia; Mirum to Acquire Bluejay Therapeutics

pharma-news-for-novo-ascendis-otsuka

Novo Nordisk Seeks FDA Approval for Higher-Dose 7.2 mg WEGOVY Injection; Ascendis Pharma Granted FDA Review Extension for TransCon CNP in Children with Achondroplasia; VOYXACT Receives FDA Fast-Track Approval for Treatment of High-Risk Primary IgAN; Sarepta Begins Next ENDEAVOR Cohort Focused on Immunosuppressive Optimization for ELEVIDYS in Advanced DMD; IMFINZI Gains U.S. Approval as the Sole Perioperative Immunotherapy for Early-Stage Gastric and GEJ Cancer

medtech-news-for-bd-rapidai-ceribell

Bracco Receives FDA Clearance for Additional Clinical Use of Max 3™ Syringeless MR Injector; RapidAI Broadens Clinical AI Portfolio with Five Newly Granted FDA Clearances; Ceribell Secures FDA 510(k) Clearance for Clarity® Algorithm in Neonatal Care; BD Introduces Surgiphor™ Irrigation System Across Europe to Enhance Surgical Patient Protection; Neurophet and The Florey Announce Strengthened Collaboration to Advance Alzheimer’s Diagnostic Solutions; VSI® Performs First-Ever Robotic Minimally Invasive Bertolotti’s Resection; BioWave® Demonstrates Safe and Effective Home-Based and War Injury Pain Relief in Latest Clinical Data

pharma-news-for-novartis-bayer-novo

Novartis Secures FDA Approval for ITVISMA; Kelun-Biotech’s Phase III Study Shows Sac-TMT + Keytruda Achieves Primary Endpoint in First-Line PD-L1-Positive NSCLC; Evoke Phase 3 Trials Failed to Show a Statistically Significant Impact on Alzheimer’s Disease Progression; Sangamo Therapeutics Gets FDA Nod for Rolling BLA Submission of ST-920 in Fabry Disease; Bayer’s HYRNUO Receives FDA Accelerated Approval for Previously Treated HER2-mutant NSCLC

medtech-news-for-zimmer-biomet-icecure-clairity

Zimmer Biomet Secures FDA Clearance for Upgraded ROSA® Knee Robotic System; IceCure’s ProSense® Cryoablation Platform Secures Swissmedic Approval for Use in Breast, Lung, Liver, and Kidney Tumors; Clairity Secures $43M Series B to Launch FDA-Authorized AI Platform for Breast Cancer Risk Prediction; Distalmotion Secures $150M to Boost U.S. Rollout of DEXTER® Robotic Surgery System; Envoy Medical Reaches Six-Month Benchmark with First 10 Patients in Acclaim® Cochlear Implant Trial; Cardiovalve Seeks CE Approval After Positive TARGET Study Results

pharma-news-for-sarepta-merck-bms

Sarepta Secures FDA Approval of Revised Prescribing Information for ELEVIDYS; Merck to Acquire Cidara Therapeutics; BMS & J&J Halt Milvexian Phase III in ACS After Interim Review; Kura Oncology & Kyowa Kirin Win FDA Green Light for KOMZIFTI in NPM1-Mutated AML; Novartis’ Phase III KLU156 (GanLum) Trial Hits Primary Endpoint

medtech-news-for-nitinotes-meduloc-kaneka

Nitinotes Obtains CE Mark Approval for EndoZip™ System; FDA Grants 510(k) for Meduloc’s Innovative Fixation Solution for Small and Long Bones; Kaneka Launches i-ED COIL™ in Europe; Motive Health Unveils New At-Home Therapy for Lower Back Relief; Gore Reports Strong 12-Month Results for VIABAHN® FORTEGRA Venous Stent in Iliocaval Disease; Vexev Marks Completion of Enrollment in AV Fistula Mapping Clinical Study

pharma-news-for-cogent-biosciences-anaptys-eledon

Cogent Biosciences’ Bezuclastinib Phase 3 PEAK Trial Positive Results for GIST; Domain Therapeutics Begins Phase I/II Trial of CCR8 Inhibitor DT-7012 in Solid Tumors; Anaptys Reports Negative Phase 2 Outcomes for Rosnilimab in Ulcerative Colitis; QOL Medical Strikes Deal to Acquire Evoke Pharma for $11 Cash Per Share; Eledon Pharmaceuticals, Inc. Unveils Phase 2 BESTOW Trial Data for Tegoprubart in Kidney Transplant Rejection Prevention at ASN Kidney Week 2025

Subscribe to our Updates

DelveInsight is dedicated to safeguarding your data. We ensure that your information is handled in compliance with relevant data privacy legislation, our internal guidelines, and our privacy policy.

Receive recent Healthcare updates directly in your inbox.

Days
loader