All Blogs
Jan 06, 2026
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
Zenas BioPharma Announces Successful Phase 3 INDIGO Study of Obexelimab in IgG4-RD Zenas BioPharma has announced positive top-line results from its pivotal Phase 3 INDIGO clinical trial evaluating obexelimab for the treatment of IgG4-Related Disease (IgG4-RD). IgG4-RD is a rare, systemic, chronic fibroinflammato...
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Jan 05, 2026
FDA Approves Omeros’ YARTEMLEA: A Breakthrough for Stem Cell Transplant Patients Facing TA-TMA
The FDA has approved YARTEMLEA (narsoplimab-wuug), marking a watershed moment in hematopoietic stem cell transplantation (HSCT) medicine. Omeros Corporation's therapeutic advance represents the first and only FDA-approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA...
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Jan 02, 2026
Is DLL3 Unlocking the New Code for the Neuroendocrine Cancers (NECs) Therapeutics’ Era?
Delta-like Ligand 3 (DLL3) is rapidly establishing a position as one of the promising targets in the treatment of aggressive Neuroendocrine Cancers (NECs), including Small Cell Lung Cancer (SCLC), Neuroendocrine Prostate Cancer (NEPC), and Large-Cell Neuroendocrine Carcinoma (LCNEC), where existing treatments deliv...
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Jan 01, 2026
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
FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy On December 23, 2025, Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system, the first transcatheter therapy using a transseptal approach, received approval from the...
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Dec 24, 2025
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
Johnson & Johnson Received FDA Approval for TRUFILL n BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma On December 18, 2025, Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and Drug Administration (FDA) had approved an expanded i...
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Dec 30, 2025
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
Novo Nordisk Secures US Approval for WEGOVY Novo Nordisk has achieved a significant regulatory milestone with the U.S. FDA approval of WEGOVY (semaglutide) for the treatment of obesity in pediatric patients aged 12 years and older. While WEGOVY has already revolutionized the adult weight management market, this ...
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Dec 23, 2025
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
Novo Nordisk Submits CagriSema for FDA Review as a Once-weekly GLP-1–amylin Combination Therapy for Weight Management Novo Nordisk has officially filed a New Drug Application (NDA) with the U.S. FDA for CagriSema, a once-weekly subcutaneous injection intended for chronic weight management. CagriSema represents a...
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Dec 31, 2025
Spondylolisthesis Medical Devices: Advancing Care Through Innovation
Spondylolisthesis, a formidable spinal condition characterized by the slippage of one vertebra over the one below it, represents a significant global health burden. It is a source of chronic, debilitating low back pain, neurological deficits, and reduced quality of life for millions. Historically, the management of...
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Dec 24, 2025
Parenteral Nutrition: A High-Growth Lifeline in Clinical Nutrition
In the intricate landscape of healthcare, maintaining optimal nutritional status is fundamental to recovery, chronic disease management, and overall patient well-being. For millions globally who cannot ingest, digest, or absorb nutrients via the conventional gastrointestinal route, an alternative lifeline is requir...
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Dec 18, 2025
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
BD Expanded BD MAX™ System Menu with New IVDR-Certified VIASURE Assays in Partnership with Certest Biotec On December 15, 2025, BD (Becton, Dickinson and Company), a leading global medical technology company, announced the expansion of its respiratory and sexually transmitted infection (STI) diagnostics po...
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