All Blogs
Nov 21, 2025
Achondroplasia Treatment: Emerging Therapies, Pathway Strategies, and Market Outlook
Achondroplasia, the most common form of dwarfism, is drawing increasing interest from pharmaceutical companies despite its rarity. Biomarin's VOXZOGO (vosoritide; a C-type natriuretic peptide; once-daily subcutaneous injection) is the only FDA-approved therapy for achondroplasia treatment. When it comes to BioMarin...
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Nov 20, 2025
Zimmer Biomet Secures FDA Clearance for Upgraded ROSA® Knee Robotic System; IceCure’s ProSense® Cryoablation Platform Secures Swissmedic Approval for Use in Breast, Lung, Liver, and Kidney Tumors; Clairity Secures $43M Series B to Launch FDA-Authorized AI Platform for Breast Cancer Risk Prediction; Distalmotion Secures $150M to Boost U.S. Rollout of DEXTER® Robotic Surgery System; Envoy Medical Reaches Six-Month Benchmark with First 10 Patients in Acclaim® Cochlear Implant Trial; Cardiovalve Seeks CE Approval After Positive TARGET Study Results
Zimmer Biomet Received U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology On November 14, 2025, Zimmer Biomet Holdings, Inc., a leading global medical technology company, announced that its enhanced ROSA® Knee with OptimiZe™ system received 510(k) clearance from the U.S. Food and Drug...
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Nov 19, 2025
Neuroprotection Devices: Advancing Brain Protection Through Medical Innovation
The preservation of neuronal function following acute insults, such as ischemic events, traumatic brain injury (TBI), or cardiac arrest, represents one of the most significant challenges in modern critical care and neurology. Neuroprotection encompasses strategies and devices designed to minimize secondary injury a...
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Nov 18, 2025
Sarepta Secures FDA Approval of Revised Prescribing Information for ELEVIDYS; Merck to Acquire Cidara Therapeutics; BMS & J&J Halt Milvexian Phase III in ACS After Interim Review; Kura Oncology & Kyowa Kirin Win FDA Green Light for KOMZIFTI in NPM1-Mutated AML; Novartis’ Phase III KLU156 (GanLum) Trial Hits Primary Endpoint
FDA Approves Major Safety and Indication Updates for Sarepta's ELEVIDYS Gene Therapy Sarepta Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved significant updates to the prescribing information for its Duchenne muscular dystrophy (DMD) gene therapy, ELEVIDYS (delandistrogene mo...
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Nov 17, 2025
TSLP Inhibitors: The New Frontier in Treating Type 2 Inflammatory Diseases
Thymic stromal lymphopoietin (TSLP) has emerged as a key target in the treatment of severe inflammatory diseases. These TSLP therapies offer a novel approach by targeting a key initiator of the inflammatory cascade. Following AstraZeneca and Amgen’s TEZSPIRE’s breakthrough approvals and a robust pipeline of emergin...
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Nov 14, 2025
Biologics and The Battle For Sight: How A New Wave of Therapies is Transforming Graves’ Orbitopathy Treatment
From steroid dependence to molecular precision, the Graves’ orbitopathy treatment is undergoing a seismic shift. But can innovation keep pace with the burden of disease? From Desperation to Discovery For decades, Graves’ orbitopathy stood as one of medicine’s most frustrating autoimmune disorders. The c...
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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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