All Blogs
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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Sep 05, 2025
Key Cardiovascular Deals of 2025: Sealing the Heartbeat
The cardiovascular space has witnessed a surge in strategic collaborations and licensing deals as companies race to address the rising global burden of heart disease with next-generation therapies. Recent transactions reflect a sharpened focus on precision cardiology, novel protein targets, and RNA-based approaches...
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Sep 03, 2025
AI Stethoscope: Transforming the Stethoscope Market and Cardiac Diagnostics with Unmatched Accuracy
Each year, cardiovascular diseases claim approximately 17.9 million lives globally, accounting for about one-third of all deaths, most due to heart attacks and strokes. Despite notable advancements in imaging and a growing cardiac diagnostics market, early detection of conditions like heart failure, atrial fibrilla...
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Sep 04, 2025
Geneseeq Technology Inc.’s GENESEEQPRIME® Assay Receives FDA 510(k) Clearance; Medtronic’s MiniMed™ 780G Gains FDA Approval for Abbott Instinct Sensor Integration and Type 2 Diabetes Use; CorNeat Vision’s Artificial Cornea Restores 20/20 Vision for Shingles-Induced Blindness; Johnson & Johnson Reports Favorable Outcomes from Real-World VARIPULSE™ PFA Study at 2025 ESC Congress; SprintRay Strengthens Dental 3D Printing Portfolio with EnvisionTEC Acquisition; Olympus Unveils Latest Imaging Platform for ENT and Urology in the U.S.
Geneseeq Technology Inc. Received FDA 510(k) Clearance for GENESEEQPRIME® Assay On September 02, 2025, Geneseeq Technology Inc. announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for its GENESEEQPRIME® NGS Tumor Profiling Assay. This in vitro diagnostic (IVD) test kit used ne...
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Sep 02, 2025
FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s; Travere Therapeutics Gains FDA Nod for FILSPARI REMS Update in IgA Nephropathy; Vanda Pharmaceuticals’ VGT-1849B Granted FDA Orphan Drug Status for Polycythemia Vera; Teva Launches First FDA-Approved Generic SAXENDA for Weight Loss; Sanofi’s WAYRILZ Gets FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia
FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved the Biologics License Application (BLA) for LEQEMBI IQLIK (lecanemab-irmb), a once-weekly 360 mg subcutaneous autoinjector designed for maintenance do...
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Sep 01, 2025
Mapping the Top Asthma Therapies: Inhaled Blockbusters and Injectable Powerhouses
Asthma: A Global Burden Driving Therapeutic Breakthroughs Asthma is a chronic inflammatory condition of the airways characterized by variable symptoms including wheezing, shortness of breath, chest tightness, and cough. It involves underlying airway inflammation, bronchial hyperresponsiveness, and reversible air...
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Aug 28, 2025
Esaote’s MyLab™ A50 and A70 Ultrasound Systems Achieve FDA 510(k) Clearance; Health Canada Approves MedMira’s Reveal® TP Rapid Test for Syphilis; MolecuLight’s Transformative Effect on Wound Care Confirmed by Large Randomized Trial; Arctx Medical’s ACC Kit Receives FDA IDE Approval and Dr. Robert Kieval Appointed CEO; Quest’s Haystack MRD Test Awarded FDA Breakthrough Device Designation for Post-Surgical Colorectal Cancer Monitoring; Sonic Healthcare USA Strengthens Oncology Diagnostics with Acquisition of Cairo Diagnostics
FDA Granted Approval to Esaote’s MyLab™ A50 and MyLab™ A70 Ultrasound Systems On August 25, 2025, Esaote announced that its MyLab™ A50 and MyLab™ A70 ultrasound systems had received FDA approval, marking a significant milestone that confirmed the systems’ compliance with the highest standards of safety and clini...
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