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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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™

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medtech-news-for-multi4-medical-ortho-development

Multi4 Medical Gains CE Mark Approval for Office-Based Bladder Cancer Treatment; FX Shoulder Solutions Achieves FDA 510(k) Clearance for FX V135® Easytech Platform; Ortho Development Launches Commercial Rollout of Trivicta® Hip Stem; Clover Podiatry Expands Foot and Wound Care Services With New Advanced Healing Center; CLiMB Study Highlights Superior Sensitivity of HelioLiver™ Blood Test Versus Ultrasound in Detecting Early-Stage HCC; Aqua Medical Unveils Promising DDW 2026 Data Showing Sustained Insulin Elimination in Type 2 Diabetes Patients

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Diabetes Care Devices: Transforming Management Through Innovation and Precision

Top Artificial Intelligence-Based Healthcare Mobile Apps and Their Use Cases

Top Artificial Intelligence-Based Healthcare Mobile Apps and Their Use Cases

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Cystinosis Treatment: Transforming a Life-Limiting Disorder into a Manageable Chronic Condition

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

jpm-healthcare-2026-highlights

JPM 2026 Recap: Who’s Winning, Who’s Catching Up, and Who’s at Risk?

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

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Top Home-Use Medical Devices Every Household Should Consider

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Cushing’s Disease Treatment: A New Era of Therapeutic Possibilities

Artificial Intelligence in Remote Patient Monitoring: Enabling Continuous, Predictive, and Personalized Care

Artificial Intelligence in Remote Patient Monitoring: Enabling Continuous, Predictive, and Personalized Care

pharma-news-for-boehringer-denali-regeneron

FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade; Denali Therapeutics’ Tividenofusp Alfa BLA Review for Hunter Syndrome Extended by FDA; Bicara’s Ficerafusp Alfa Earns FDA Breakthrough Tag for 1L HPV-Negative Head & Neck Cancer; BeOne Medicines’ Sonrotoclax Granted FDA Breakthrough Designation for Cancer Treatment; FDA Clears LIBTAYO for Adjuvant Use in Cutaneous Squamous Cell Carcinoma

medtech-news-for-vektor-medical-tosoh-zimmer-biomet

Vektor Medical Receives CE Mark for vMap; Tosoh’s GR01 HbA1c Analyzer Gains FDA 510(k) Clearance; Zimmer Biomet Acquires Monogram Technologies; Olympus Partners with W. L. Gore & Associates to Distribute GORE® VIABIL® Biliary Stent Globally; Medtronic Launches U.S. IDE Study on Hugo™ Robotic Surgery System for Gynecology; Envoy Medical Secures FDA Clearance to Advance Pivotal Trial to Final Stage Following Promising Three-Month Results

pharma-news-for-aminex-eccogene-taysha

Aminex Therapeutics Secures FDA Orphan Drug Designation for AMXT 1501 + DFMO in Neuroblastoma; Eccogene Gets FDA Nod to Begin Phase IIa MOSAIC Trial of ECC4703 + ECC0509 in MASH; Orca Bio’s Orca-T Earns FDA Priority Review for Hematologic Malignancies; Alto Neuroscience Gains FDA Fast Track for ALTO-101 in Cognitive Impairment Linked to Schizophrenia; Taysha Gene Therapies Wins FDA Breakthrough Therapy Status for TSHA-102 in Rett Syndrome

pharma-news-for-regeneron-kedrion-crinetics

Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year; Eli Lilly’s INLURIYO Approved for ER+, HER2-, ESR1-Mutated Advanced Breast Cancer; Janssen’s TREMFYA Secures FDA Nod for Pediatric Plaque Psoriasis and Psoriatic Arthritis; Kedrion Biopharma’s QIVIGY Approved for Primary Humoral Immunodeficiency in Adults; Crinetics Pharma Wins FDA Approval for First Daily Pill, PALSONIFY, for Rare Growth Disorder

pharma-news-for-merck-incyte-biocon

Merck Wins FDA Approval for KEYTRUDA QLEX for Subcutaneous Use in Adults With Solid Tumors; Incyte Gains FDA Nod for OPZELURA Cream in Children Aged 2–11 With Atopic Dermatitis; Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic Syndrome; MavriX Bio Secures FDA Fast Track for MVX-220 Gene Therapy in Angelman Syndrome; Biocon Biologics Gets FDA Approval for Denosumab Biosimilars BOSAYA and AUKELSO

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

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