All Blogs
Oct 17, 2025
Seagen’s TUKYSA Powers Pfizer’s Next HER2-Positive Breast Cancer Milestone
Pfizer’s oncology pipeline has achieved a second positive phase III trial in HER2-positive breast cancer within roughly a year. This latest success involves TUKYSA, a HER2-targeted tyrosine kinase inhibitor that Pfizer acquired through its $43 billion purchase of Seagen. In patients with HER2-positive metastatic...
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Oct 16, 2025
Scanogen’s Bloodstream Infection Assay Earns FDA Breakthrough Device Status; Lapsi Health Launches Keikku 2.0; Medtronic BrainSense™ Adaptive DBS Earns 2025 TIME Best Inventions Honor; Photocure Partners with Intelligent Scopes Corporation to Advance AI Integration in Blue Light Cystoscopy; Conformal Medical Expands CONFORM Trial to Europe; Materna Medical Presents Study on At-Home Patient Outcomes: Experienced vs. Naïve Dilator Users
Scanogen Received FDA Breakthrough Device Designation for Rapid Bloodstream Infection Assay On October 15, 2025, Scanogen Inc., a molecular diagnostics innovator developing next-generation infectious disease detection technologies, announced that the U.S. Food and Drug Administration (FDA) granted Breakthr...
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Oct 15, 2025
Artificial Intelligence in Remote Patient Monitoring: Enabling Continuous, Predictive, and Personalized Care
The convergence of Artificial Intelligence (AI) and Remote Patient Monitoring (RPM) marks a pivotal shift toward predictive, continuous, and patient-centric healthcare. As chronic diseases rise globally, healthcare systems are under pressure to deliver timely, personalized interventions without overburdening hospit...
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Oct 14, 2025
FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade; Denali Therapeutics’ Tividenofusp Alfa BLA Review for Hunter Syndrome Extended by FDA; Bicara’s Ficerafusp Alfa Earns FDA Breakthrough Tag for 1L HPV-Negative Head & Neck Cancer; BeOne Medicines’ Sonrotoclax Granted FDA Breakthrough Designation for Cancer Treatment; FDA Clears LIBTAYO for Adjuvant Use in Cutaneous Squamous Cell Carcinoma
FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade Boehringer Ingelheim’s JASCAYD (nerandomilast) has received FDA approval as an oral treatment for adults with idiopathic pulmonary fibrosis (IPF), marking the first new therapy for the condition in over a decade. JASCAYD is the first and...
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Oct 13, 2025
Expanding Horizons in Chronic Pruritus Treatment: Emerging Therapies Target Diverse Mechanisms
Chronic pruritus, characterized by itching that persists for more than six weeks, is a multifaceted condition that may stem from dermatologic, systemic, neurologic, or psychogenic factors. It has a profound impact on patients’ quality of life and is increasingly recognized as a standalone clinical entity. DelveInsi...
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Oct 10, 2025
Boehringer Ingelheim’s JASCAYD Brings Hope Back to IPF Patients After a Decade of Waiting
Over a decade after launching one of the first treatments for idiopathic pulmonary fibrosis, Boehringer Ingelheim is rejuvenating its presence in the rare lung disease arena with a newly approved therapy. On October 7, the FDA approved JASCAYD, marking the first new IPF treatment in over ten years. The approval fol...
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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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