All Blogs
Nov 13, 2025
Nitinotes Obtains CE Mark Approval for EndoZip™ System; FDA Grants 510(k) for Meduloc’s Innovative Fixation Solution for Small and Long Bones; Kaneka Launches i-ED COIL™ in Europe; Motive Health Unveils New At-Home Therapy for Lower Back Relief; Gore Reports Strong 12-Month Results for VIABAHN® FORTEGRA Venous Stent in Iliocaval Disease; Vexev Marks Completion of Enrollment in AV Fistula Mapping Clinical Study
Nitinotes Received CE Mark Approval of EndoZip™, the First Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty On November 06, 2025, Nitinotes Ltd., a medical device company focused on transforming obesity treatment, announced that it had received CE Mark approval for its EndoZip™ System, th...
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Nov 12, 2025
Biopsy Devices: Advancing Diagnostic Precision in Modern Healthcare
The field of oncology and pathology hinges on one definitive step: the biopsy. Serving as the gold standard for diagnosing a vast majority of cancers and other diseases, the process of obtaining tissue samples has driven continuous technological innovation. The biopsy device market represents a vital sector within ...
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Nov 11, 2025
Cogent Biosciences’ Bezuclastinib Phase 3 PEAK Trial Positive Results for GIST; Domain Therapeutics Begins Phase I/II Trial of CCR8 Inhibitor DT-7012 in Solid Tumors; Anaptys Reports Negative Phase 2 Outcomes for Rosnilimab in Ulcerative Colitis; QOL Medical Strikes Deal to Acquire Evoke Pharma for $11 Cash Per Share; Eledon Pharmaceuticals, Inc. Unveils Phase 2 BESTOW Trial Data for Tegoprubart in Kidney Transplant Rejection Prevention at ASN Kidney Week 2025
Cogent Biosciences Announces Positive Outcomes from the Phase 3 PEAK Trial of Bezuclastinib in Gastrointestinal Stromal Tumors Cogent Biosciences, Inc. announced positive topline results from its Phase 3 PEAK trial evaluating bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant Gastroin...
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Nov 10, 2025
UCB’s KYGEVVI Approval: A Breakthrough for Thymidine Kinase 2 Deficiency
In a significant milestone for the rare disease community, the FDA approved KYGEVVI (doxecitine and doxribtimine) in November 2025, marking the first and only approved treatment for thymidine kinase 2 deficiency (TK2d). This breakthrough approval represents a transformative moment for patients and families facing t...
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Nov 07, 2025
Bayer’s Lynkuet Ushers in New Class of Therapies for Menopause
After a brief delay earlier this year, and following its world-first approval in the UK over the summer, Bayer has now secured FDA approval for its novel therapy, expanding the limited range of nonhormonal options available for managing common menopausal symptoms. The FDA has approved Bayer’s dual neurokinin (NK) i...
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Nov 06, 2025
Nexalin Technology Secures Israeli Regulatory Clearance for Gen-2 SYNC 15 mA DIFS™ Neurostimulation System; W&H Medical Launches First U.S.–Cleared Piezo & Drill Combo Console for Rhinoplasty & Facial Surgery; Elevaris Launches CDMO Services and Procedural Needle Offerings in EMEA; Cardinal Health Successfully Acquired Solaris Health; 4WEB Medical Sets a New Standard in Implant-Based Therapy; BD Reaches Key Milestone in AGILITY Trial Evaluating Revello™ Vascular Covered Stent for PAD
Nexalin Technology Announced Regulatory Approval to Sell Gen 2 SYNC, 15 mA Neurostimulation DIFS™ Device in Israel On October 30, 2025, Nexalin Technology, Inc., a company recognized for its Deep Intracranial Frequency Stimulation (DIFS™) technology, announced that its Gen-2 Console (“SYNC”) 15 mA neurosti...
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Nov 05, 2025
AI Hospitals of the Future–Where Robotics, Predictive Analytics, and Compassion Converge
The global healthcare landscape is undergoing one of the most transformative revolutions in modern history. At the heart of this evolution lies Artificial Intelligence (AI), a force that is not just augmenting medical workflows but reshaping how hospitals function, how care is delivered, and how humanity interacts ...
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Nov 04, 2025
Intensity Therapeutics Publishes Compelling Clinical Data for INT230-6 in Advanced Cancers; UCB Wins FDA Approval for KYGEVVI for Rare Mitochondrial Disease TK2d; BrainXell Therapeutics Unveils Promising Preclinical Data for iPSC-Derived Neuronal Therapy in Parkinson’s Disease; CARsgen Therapeutics Reports Encouraging Clinical Data for Allogeneic CAR-T Products in Hematologic Malignancies; Novo Nordisk’s $9 Billion Counterbid for Metsera Ignites Landmark Obesity Drug Market Battle
Intensity Therapeutics Publishes Compelling Clinical Data for INT230-6 in Advanced Cancers Intensity Therapeutics, Inc. (Nasdaq: INTS) announced the publication of its Phase 1/2 clinical results for INT230-6. The comprehensive study evaluated the intratumoral therapy's safety, efficacy, and mechanism of action a...
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Oct 31, 2025
Pharma Rivalry Intensifies: Novo Nordisk Looks to Wrest Metsera from Pfizer
In an unprecedented move that has sent shockwaves through the pharmaceutical industry, Danish drugmaker Novo Nordisk launched an unsolicited ~$9 billion bid to acquire obesity-focused biotech Metsera, directly challenging a deal Pfizer had already secured. The aggressive counteroffer, announced on October 30, 2025,...
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Nov 03, 2025
New Lupus Nephritis Drugs on the Horizon: 6 Promising Therapies Eyeing Newly Approved GAZYVA’s Market Space
Roche’s GAZYVA FDA approval has already rewritten the lupus nephritis playbook — it turned a long-standing oncology B-cell drug into a validated, kidney-saving option. It proved that aggressive B-cell targeting can materially boost complete renal responses when added to standard therapy. The GAZYVA approval (driven...
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