All Blogs
Sep 19, 2025
Alcohol Use Disorder: A High-Burden Disease with Untapped Market Promise
Insights around AUD patient burden Over the years, AUD has emerged as a pressing global health challenge, with prevalence steadily rising, particularly in the United States and parts of Europe. This upward trend is fueled by modern lifestyle pressures, work-related stress, anxiety, and shifting social habits, as...
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Sep 18, 2025
Amber Implants Wins FDA 510(k) Clearance for VCFix® Spinal System; Merit Medical’s Embosphere Microspheres Receive CE Mark for Genicular Artery Embolisation in Knee OA; Rejuva Fresh® Introduces REVIVO™ Dual Summit 1927/1550 Fractional Laser System; GE HealthCare Eyes Acquisition of icometrix to Enhance Neurology Imaging and Brain MRI Assessment Tools; Diality Reports First Patient Dosed in Moda-flx Home IDE PRESCRIBE Trial; DUBSTENT DIABETES Trial Begins Enrollment: Aiming to Optimize PCI Outcomes in Patients with Diabetes
Amber Implants Secured FDA 510(k) Clearance for VCFix® Spinal System: A Next-Generation Solution for Vertebral Compression Fractures On September 17, 2025, Amber Implants, a pioneering medical technology company focused on developing advanced solutions for spinal injuries, announced that it received cleara...
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Sep 17, 2025
The Rise of AI-Powered Point-of-Care Diagnostics: Transforming Real-Time Patient Care
Point-of-care (POC) diagnostics have revolutionized healthcare by enabling rapid, on-site testing that delivers actionable results without the delays of traditional laboratory processes. For instance, over 1.5 billion POC tests are performed annually worldwide, ranging from portable blood glucose monitors to point-...
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Sep 16, 2025
Lion TCR Secures Triple FDA Milestones with IND Clearance for Chronic Hepatitis B; Corstasis Therapeutics Wins FDA Approval for ENBUMYST Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease; Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness; Greenwich LifeSciences’ GLSI-100 Granted FDA Fast Track Designation; Akeso’s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia
Lion TCR Secures Triple FDA Milestones for Chronic Hepatitis B with IND Clearance of TCR-T Therapy Lion TCR announced that the FDA has cleared its Investigational New Drug (IND) application for LioCyx-M004, authorizing the initiation of phase Ib/II clinical trials in patients with chronic hepatitis B (CHB). The ...
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Sep 15, 2025
The Race for Next-generation Wet AMD Therapies: Shaping the Future of Vision
Neovascular age-related macular degeneration (nAMD or Wet AMD) is a progressive retinal condition and a primary cause of central vision loss among individuals over 60 years old. While it represents only 10–15% of overall AMD cases, it is responsible for nearly 90% of severe vision impairment linked to the disease. ...
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Sep 11, 2025
ONWARD Medical’s ARC-EX System Gains CE Mark; Microbot Medical Secures FDA 510(k) Clearance for LIBERTY® Endovascular Robotic System; Fraiya Launches Major NHS Clinical Trial Using AI for Pregnancy Ultrasounds; Medtronic Hugo™ Robotic-assisted Surgery System in Hernia Repair Met Safety and Effectiveness Endpoints; Willow Launches Willow Wave, Pioneering a New Standard in Breastfeeding; Vivalink Launches New Adhesive to Improve Wearable ECG Performance
ONWARD Medical Received CE Mark for ARC-EX, Enabling Commercial Launch of Breakthrough Spinal Cord Stimulation System in Europe On September 8, 2025, ONWARD Medical N.V., a leading neurotechnology company developing therapies to restore movement, function, and independence for individuals with spinal cord ...
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Sep 10, 2025
From Lab to Bedside: The Rise of AI-Enabled Digital Pathology
Pathology—the discipline of diagnosing disease through tissue analysis, has long depended on glass slides and microscopes. Today, digital pathology is undergoing a remarkable shift, as whole-slide imaging (WSI) and artificial intelligence (AI) come together to streamline lab workflows, accelerate diagnoses, and enh...
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Sep 09, 2025
NeuroNOS’ BA-101 Granted FDA Orphan Drug Status for Glioblastoma; Takeda’s VONVENDI Approval Expanded for Von Willebrand Disease in Adults and Children; Telix Gains FDA Nod on Resubmission Pathway for TLX101-CDx NDA; Saol Therapeutics Receives FDA CRL for SL1009 in Pyruvate Dehydrogenase Complex Deficiency; FDA Grants Breakthrough Therapy Designation to Boehringer’s HERNEXEOS for HER2-Mutant Advanced NSCLC
NeuroNOS Secures FDA Orphan Drug Designation for BA-101 in Glioblastoma NeuroNOS, a biopharmaceutical company specializing in neurological disorders and neuro-oncology and a subsidiary of Beyond Air, announced that the FDA has granted Orphan Drug Designation (ODD) to its lead investigational therapy, BA-101, for...
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Sep 08, 2025
PCSK9 Inhibition in Cardiovascular Care: Unmet Needs, Market Evolution, and Emerging Players
The Unmet Need in Cholesterol Management Cardiovascular Diseases (CVDs) continue to be one of the leading causes of morbidity and mortality worldwide, primarily driven by underlying lipid disorders, including Hypercholesterolemia (familial and non-familial hypercholesterolemia), Dyslipidemia, Atherosclerotic Car...
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Sep 12, 2025
DUPIXENT’s Launch Brings Next Chapter of Biologics in COPD
COPD management has progressively centered on bronchodilator-based regimens, with Long-acting Muscarinic Antagonists (LAMAs) and Long-acting Beta-agonists (LABAs) forming the therapeutic core. Dual LAMA/LABA therapy is standard for moderate disease, while triple therapy with Inhaled Corticosteroids (ICS) is reserve...
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