Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Sonomotion Secures FDA Clearance for Break Wave™ Lithotripsy System; Aidoc Earns FDA Clearance for Comprehensive AI Foundation Model in Healthcare; BD and Ypsomed Deepen Partnership to Serve Expanding Biologics Market; Omnia Medical Launches FDA-Approved PsiF DNA™ System to Market; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; NEURO PMR Data Validates Hyperfine’s Diagnostic Precision and Patient-Centered Care

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Nxera Pharma Confirms Positive Phase 3 Findings for Daridorexant in South Korea; AstraZeneca Strengthens Oncology Pipeline in China With GPC3 Armored CAR-T Rights From AbelZeta; AbbVie Shares Topline Findings from Phase 3 EPCORE DLBCL-1 Study of Epcoritamab; ImmunityBio Achieves Prolonged Complete Response Using Chemotherapy-Free CD19 CAR-NK Platform; Sobi Wins EU Approval for ASPAVELI to Treat C3G and Primary IC-MPGN

medtech-news-for-medtronic-neurolief-haemonetics

Medtronic Diabetes Secures FDA Clearance for MiniMed Go™ Smart MDI Platform; Neurolief Achieves FDA PMA Approval for Novel At-Home Brain Stimulation Therapy for Depression; Haemonetics Completes Acquisition of Vivasure Medical Limited; Boston Scientific Enters Agreement to Acquire Valencia Technologies; Butterfly Medical Completes Pivotal Trial for Minimally Invasive BPH Therapy; TYBR Health Announces First U.S. Clinical Use of the B3 GEL™ System

pharma-news-for-insilico-merck-sanofi

Insilico Medicine Moves Garutadustat into Phase IIa Following First Patient Dosing; Sustained Therapeutics Reports Encouraging Phase 2 Outcomes for Long-Acting Non-Opioid Chronic Pain Drug; ZYUS Life Sciences Shares Early Results from Ongoing Phase 2a UTOPIA-1 Pain Trial; Merck Advances KRAS G12C Program With Phase 3 Calderasib Combination Study in NSCLC; Sanofi’s Teizeld Gains EU Approval for Early-stage Type 1 Diabetes

medtech-news-for-gore-stereotaxis-stimlabs

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

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

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