Category Regulatory

Mirai Bio to Reveal Two Next-Gen Targeted Nucleic Acid Delivery Programs Beyond the Liver at ASGCT 2026

Mirai Bio to Debut Two Next-Generation Programs for Extrahepatic Targeted Nucleic Acid Delivery at the ASGCT 2026 Annual Meeting Mirai Bio, a company focused on enabling the next generation of nucleic acid therapeutics through advanced delivery technologies, has announced its…

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Pixee Medical Secures FDA 510(k) Clearance for Next-Gen Knee+ NexSight Augmented Reality Platform

Pixee Medical Secures U.S. Food and Drug Administration 510(k) Clearance for Next-Generation Knee+ NexSight on Advanced Augmented Reality Platform Pixee Medical, a recognized innovator in augmented reality (AR) navigation for orthopedic procedures, has achieved a significant regulatory milestone with the…

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Sunnybrook Health Sciences Centre Secures $41 Million Donation to Strengthen Canada’s Leadership in Clinical Trials

Sunnybrook Receives $41 Million Donation to Strengthen Canada’s Global Leadership in Clinical Trials Sunnybrook Health Sciences Centre has announced a transformative $41 million philanthropic investment aimed at reshaping the future of clinical research through the expansion of Sunnybrook Clinical Trials.…

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Arrowhead Pharmaceuticals Secures Positive CHMP Opinion for REDEMPLO® (plozasiran) in FCS Treatment

Arrowhead Pharmaceuticals Secures Positive CHMP Recommendation for REDEMPLO® (plozasiran) to Treat Elevated Triglycerides in Adults with Familial Chylomicronemia Syndrome in Europe Arrowhead Pharmaceuticals has taken a significant step forward in advancing treatment options for patients living with the rare and…

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EndoTool IV Data at AACE Highlights Near Elimination of Severe Hypoglycemia Across 19 Hospitals

New EndoTool IV Data Presented at AACE Demonstrates Near Elimination of Severe Hypoglycemia Across 19 Hospitals Glooko, Inc., a globally integrated digital health company dedicated to improving diabetes management and glycemic safety across care settings, has unveiled new clinical evidence…

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Ironwood Pharmaceuticals to Present HCP Insights on TPN Burden in Short Bowel Syndrome at Digestive Disease Week® 2026

Ironwood Pharmaceuticals to Present Real-World Clinician Insights on Total Parenteral Nutrition Burden in Short Bowel Syndrome at Digestive Disease Week® 2026 Ironwood Pharmaceuticals, Inc. has announced that it will present a series of new data analyses and clinical insights at…

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IMAAVY® (nipocalimab-aahu) Demonstrates Sustained Disease Control Beyond Two Years Across a Broad gMG Patient Population

IMAAVY® (nipocalimab-aahu) Demonstrates Durable, Over Two-Year Disease Control Across a Broad gMG Patient Population Johnson & Johnson has unveiled new clinical findings highlighting the long-term efficacy and safety of IMAAVY® (nipocalimab-aahu) in patients with generalized myasthenia gravis (gMG). The data,…

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OrganaBio and RxMP Therapeutics Forge Manufacturing Partnership to Advance RMP-402 Hemostatic Therapy

OrganaBio and RxMP Therapeutics Forge Manufacturing Alliance to Advance Development of RMP-402 Hemostatic Therapy OrganaBio and RxMP Therapeutics have announced a strategic manufacturing partnership aimed at advancing the development of a novel therapy designed to rapidly control severe bleeding. Under…

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Shields Health Solutions Collaborates with Columbus Regional Health to Expand Access to Specialty Pharmacy Services

Shields Health Solutions Collaborates with Columbus Regional Health to Expand Access to Specialty Pharmacy Care Shields Health Solutions, a leading specialty pharmacy integrator and accelerator in the United States, has announced a new strategic partnership with Columbus Regional Health (CRH),…

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AHF Initiates Statewide Campaign Calling for Full Reinstatement of Florida’s AIDS Drug Assistance Program

AHF Initiates Statewide Campaign Calling for Full Reinstatement of Florida’s AIDS Drug Assistance Program The AIDS Healthcare Foundation (AHF) has launched a statewide public awareness campaign urging Ron DeSantis and the Florida Legislature to take immediate and permanent action to…

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