All Blogs
Nov 27, 2025
Bracco Receives FDA Clearance for Additional Clinical Use of Max 3™ Syringeless MR Injector; RapidAI Broadens Clinical AI Portfolio with Five Newly Granted FDA Clearances; Ceribell Secures FDA 510(k) Clearance for Clarity® Algorithm in Neonatal Care; BD Introduces Surgiphor™ Irrigation System Across Europe to Enhance Surgical Patient Protection; Neurophet and The Florey Announce Strengthened Collaboration to Advance Alzheimer’s Diagnostic Solutions; VSI® Performs First-Ever Robotic Minimally Invasive Bertolotti’s Resection; BioWave® Demonstrates Safe and Effective Home-Based and War Injury Pain Relief in Latest Clinical Data
FDA Approved Expanded Indication for Max 3™ Syringeless MR Injector from Bracco On November 25, 2025, Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., announced that the U.S. Food and Drug Administration (FDA) expanded the indication for its Max 3™ Rapid Exchange and Syringeless Injector fo...
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Dec 01, 2025
The Next Wave of Metastatic Colorectal Cancer Drug Treatment: 6 Therapies Poised to Change the Landscape
The metastatic colorectal cancer drug treatment landscape has advanced considerably, with a growing range of targeted therapies, immunotherapies, and innovative agents now complementing standard chemotherapy. The mCRC treatment paradigm is structured across multiple lines of therapy. First-line (1L) treatment typic...
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Nov 28, 2025
Arrowhead Hits the Mark in FCS Treatment with REDEMPLO Approval—Now Comes the Ionis Challenge
Arrowhead Pharmaceuticals has reached a transformational milestone with the FDA’s approval of REDEMPLO (plozasiran) on November 18, 2025—marking the company’s first FDA-approved medicine and the first-ever FDA-approved siRNA therapeutic for familial chylomicronemia syndrome (FCS) treatment. This historic approval r...
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Nov 25, 2025
Novartis Secures FDA Approval for ITVISMA; Kelun-Biotech’s Phase III Study Shows Sac-TMT + Keytruda Achieves Primary Endpoint in First-Line PD-L1-Positive NSCLC; Evoke Phase 3 Trials Failed to Show a Statistically Significant Impact on Alzheimer’s Disease Progression; Sangamo Therapeutics Gets FDA Nod for Rolling BLA Submission of ST-920 in Fabry Disease; Bayer’s HYRNUO Receives FDA Accelerated Approval for Previously Treated HER2-mutant NSCLC
Novartis Secures FDA Approval of ITVISMA for Children Two Years and Older, Teens, and Adults with Spinal Muscular Atrophy (SMA) Novartis has announced a significant expansion in the treatment landscape for Spinal Muscular Atrophy (SMA) with the FDA approval of ITVISMA (onasemnogene abeparvovec-brve). This one-ti...
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Nov 26, 2025
Bioanalytical Testing Services: Advancing Drug Development and Precision Medicine
The global pharmaceutical and biotechnology industries rely on bioanalytical testing services to navigate the complex, highly regulated drug development process. These specialized services are critical for measuring drug concentration, metabolite levels, and biological markers within complex biological matrices (su...
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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 24, 2025
Huntington’s Disease Treatment Meets Its Match: Gene Therapy in Action
Huntington’s Disease: Genetics, Symptoms, and Therapeutic Gaps Huntington’s disease is often described as having Amyotrophic Lateral Sclerosis (ALS), Parkinson’s, and Alzheimer’s rolled into one—a neurodegenerative triple threat that devastates motor control, cognition, and behavior in a single blow. Caused by t...
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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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