All Blogs
Dec 11, 2025
A New Star at SABCS 2025: BioNTech–BMS’s Pumitamig Redefines Next-Gen Immunotherapy
The 2025 San Antonio Breast Cancer Symposium (SABCS), the world’s leading forum for breast cancer research, highlights cutting-edge progress across the full spectrum of breast cancer, from prevention and molecular biology to new therapies and survivorship. This year’s focus includes several emerging strategies to r...
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Dec 11, 2025
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
Bendit Announced the FDA Clearance for the Bendit17™ Steerable Microcatheter On December 10, 2025, Bendit Technologies announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for the Bendit17™ Microcatheter, which became the smallest steerable microcatheter available on the market...
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Dec 10, 2025
A New Era of Dermatology: In-Depth Analysis of Energy-Based Aesthetic Device Applications
The pursuit of enhanced appearance, well-being, and confidence has driven a remarkable revolution in modern medicine, with energy-based aesthetic devices standing at the epicenter of this transformation. These specialized apparatuses, employing energies such as lasers, radiofrequency (RF), ultrasound, and cryolipol...
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Dec 09, 2025
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
Kallyope Reports Successful Phase 2b Trial Outcomes for Elismetrep in Acute Migraine Treatment Kallyope, a late-stage biotechnology company focused on neurological and metabolic therapies, announced positive results from its Phase 2b dose-ranging study of the lead candidate, elismetrep (K-304), for the acute tre...
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Dec 08, 2025
The Future of HIV Associated Neurocognitive Disorders Treatment: A Growing Crisis with Limited Solutions
HIV-associated neurocognitive disorders, commonly referred to as HAND, represent one of the most persistent neurological complications affecting people living with HIV. Despite remarkable advances in antiretroviral therapy that have transformed HIV from a fatal disease into a manageable chronic condition, neurocogn...
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Dec 04, 2025
Medtronic announced FDA clearance of Hugo™ robotic-assisted surgery system for urologic surgical procedures (Regulatory Update); FDA Approves IsoPSA®, Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test (Regulatory Update); Innovative Medical Equipment Launched Full Headcap for Migraine and Head Pain Management (Commercial Update); Astrin Biosciences Launched Certitude™ Breast, the First Non-Imaging Breast Cancer Detection Test (Commercial Update); SeaStar Medical Announced FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI (Clinical Update); MiRus Announced First Cases with EUROPA® Posterior Cervical Fusion System with New Technology Add-on Payment (NTAP) (Clinical Update)
Medtronic announced FDA clearance of Hugo™ robotic-assisted surgery system for urologic surgical procedures (Regulatory Update) On December 03, 2025, Medtronic (NYSE: MDT), a global leader in surgical innovation, announced that the U.S. Food and Drug Administration had granted clearance for the Hugo™ robotic-ass...
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Dec 03, 2025
Epilepsy Monitoring Devices: Transforming Patient Care and Seizure Management
Epilepsy affects nearly 50 million people globally, making it one of the most common neurological disorders, with about 80% of cases occurring in low- and middle-income countries where diagnostic and treatment resources are limited. Yet with timely and appropriate care, up to 70% of individuals with epilepsy can be...
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Nov 27, 2025
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
FDA Approved Expanded Indication for Max 3™ Syringeless MR Injector from Bracco On November 25, 2025, Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., announced that the U.S. Food and Drug Administration (FDA) expanded the indication for its Max 3™ Rapid Exchange and Syringeless Injector fo...
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Dec 02, 2025
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
Novo Nordisk Submits FDA Application for 7.2 mg Dose of WEGOVY Injection Novo Nordisk has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a higher, investigational 7.2 mg dose of its once-weekly semaglutide injection, marketed as WEGOVY, f...
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Dec 05, 2025
Evolving Landscape of Anti-GPC3 Targeted Therapies: ADCs, CAR-T Cells, and Beyond
Glypican-3 (GPC3) has emerged as one of the most promising therapeutic targets in oncology, particularly in hepatocellular carcinoma and select solid tumors. As a cell surface heparan sulfate proteoglycan that is overexpressed in approximately 75% of hepatocellular carcinoma cases while remaining virtually absent i...
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