All Blogs
Oct 09, 2025
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
Vektor Medical Secures CE Mark for vMap, Bringing the Benefits of Non-Invasive Arrhythmia Mapping to Europe On October 7, 2025, Vektor Medical, a leading innovator in cardiac arrhythmia care, received CE Mark approval for its vMap® System, a non-invasive, AI-powered technology that converts standard 12-lea...
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Oct 08, 2025
Artificial Intelligence in Clinical Trials: Transforming Drug Development Efficiency and Precision
The integration of Artificial Intelligence in clinical trials marks one of the most transformative shifts in modern drug development. As the pharmaceutical industry grapples with rising R&D costs, long trial timelines, and high attrition rates, AI in clinical trials has emerged as a catalyst for optimizing desi...
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Oct 07, 2025
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
Aminex Therapeutics Secures FDA Orphan Drug Designation for AMXT 1501 + DFMO in Neuroblastoma Aminex Therapeutics, Inc., a clinical-stage biotechnology company developing novel cancer therapies, announced that the FDA has granted Orphan Drug Designation (ODD) to AMXT 1501 in combination with difluoromethylornith...
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Oct 06, 2025
Innovative RoA in Traumatic Brain Injury Treatment: Intranasal and Intrathecal Approaches
Traumatic brain injury should not be viewed solely as an acute condition; it can also manifest as a chronic disorder that adversely impacts quality of life and is associated with long-term health consequences. The development of services for TBI care can be guided by public health insights and policy awareness rega...
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Oct 03, 2025
Shaping the Future of Ovarian Cancer Treatment: From PARP Inhibitors to ADCs
Ovarian cancer ranks among the most lethal gynecological cancers, largely because it is often detected at advanced stages and recurs frequently despite initial response to surgery and chemotherapy. Most cases are epithelial, with High-grade Serous Ovarian Cancer (HGSOC) being the most common and aggressive, typical...
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Oct 01, 2025
Wearables 2.0: The Next Wave of Clinical-Grade Wearable Medical Devices
Not long ago, the word wearable instantly brought to mind fitness trackers counting steps or smartwatches nudging users to stand up. While those devices sparked the early boom, the next chapter, Wearables 2.0, is unfolding at the intersection of healthcare and technology. Today, wearable medical devices are no long...
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Oct 02, 2025
Zimmer Biomet Secures Japan PMDA Approval for First Iodine-Treated Total Hip Replacement System; FluidAI Medical’s Origin™ Earns FDA 510(k) Clearance; Sky Labs Introduces CART BP; Forward Science Collaborates with Sage Dental to Launch PerioStōm; iotaMotion Sets New Benchmark with 1,000+ Cochlear Implant Procedures Using iotaSOFT®; Relief Cardiovascular Completes First Human Implant of Pioneering Smart Valve for Heart Failure Congestion
Zimmer Biomet Announced Japan PMDA Approval of World's First Iodine-Treated Total Hip Replacement System On September 25, 2025, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that Japan’s Pharmaceutical and Medical Devices Agency (PMDA) had approved the iTaperloc® Complete a...
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Sep 30, 2025
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
Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year Regeneron Pharmaceuticals, Inc. announced that the FDA has approved EVKEEZA (evinacumab-dgnb) ANGPTL3 antibody, for children aged 1 to under 5 years with homozygous familial hypercholesterolemia (HoFH). This expands the indication from...
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Sep 29, 2025
Essential Thrombocythemia Treatment—Why the US Lags Behind Europe?
Affecting roughly 1–2 people per 100,000 each year, essential thrombocythemia is often silent, discovered during routine blood tests, yet it can quietly impact quality of life. The total number of diagnosed cases of essential thrombocythemia in the US was approximately 167,000 cases in 2024. In the United States, t...
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Sep 26, 2025
Leo’s ANZUPGO Cream: First FDA-Approved Treatment for Adults with Moderate-to-Severe Chronic Hand Eczema
Chronic hand eczema is more than just dry, itchy skin—it’s a persistent condition that affects up to 10% of adults worldwide, often interfering with daily life and work. Chronic hand eczema is characterized by either a persistent or relapsing course of hand eczema, or by eczema that does not respond to standard tre...
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