Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

GE HealthCare Secures FDA 510(k) Clearance and CE Mark for Allia Moveo, Completing First Global Installation; China NMPA Approves Promega’s MSI Test as a Companion Diagnostic for KEYTRUDA; Oracle Life Sciences AI Data Platform Unifies Data and Agentic Intelligence to Accelerate Breakthroughs and Boost Commercial Outcomes; Quest Diagnostics Launches New Blood Test for Detecting Minimal Residual Myeloma; RevBio Secures FDA Clearance to Begin Pivotal Study of Cranial Bone Glue; Hyperfine Reports Breakthrough Clinical Findings on Swoop® System’s Increased Sensitivity in Stroke Detection

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pharma-news-for-novo-nordisk-sanofi-kyowa-kirin

Novo Nordisk A/S Announces that CagriSema Delivered Superior Outcomes in REIMAGINE 2; Sanofi’s Venglustat Clears all Primary Hurdles in Phase 3 Gaucher Disease Trial; Kyowa Kirin Reacquires Full Development and Commercialization Rights for Rocatinlimab; IMFINZI Receives CHMP Recommendation for Perioperative Treatment in Patients with Resectable Gastric and Gastroesophageal Cancers; Tenpoint Wins FDA Approval for First-Ever Combination Presbyopia Eye Drop

medtech-news-for-seno-medical-spine-innovation-laborie

Seno Medical Secures EU MDR CE Mark for Next-Generation Imagio® Imaging System; Spine Innovation Announces FDA 510(k) Clearance of LOGIC™ Titanium Expandable Interbody System; Laborie Adds JADA® System to Obstetrics Portfolio for Rapid PPH Control; Olympus Introduces SecureFlex™ Single-Use Fine Needle Biopsy Device in the U.S.; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; Myra Vision Begins U.S. ADAPT Glaucoma Study, Treating First Participant

pharma-news-for-sanofi-corcept-corxel

Sanofi Strengthens Amlitelimab’s Position in Atopic Dermatitis; Corcept Announces Statistically Significant Overall Survival Benefit in Phase 3 ROSELLA Study; CORXEL Raises $287M Series D1 for Cardiometabolic Pipeline Expansion; IntraBio’s Levacetylleucine Demonstrates Positive Results in Pivotal Ataxia-Telangiectasia Trial; Otsuka Secures FDA Acceptance and Priority Review for Centanafadine in ADHD

medtech-news-for-sonomotion-aidoc-bd

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

pharma-news-for-nxera-astrazeneca-abbvie

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

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