Category Regulatory

U.S. FDA Grants Priority Review to Gilead’s NDA for Once-Daily HIV Regimen Combining Bictegravir and Lenacapavir

U.S. FDA Accepts Priority Review for Gilead’s Once-Daily HIV Therapy Combining Bictegravir and Lenacapavir Gilead Sciences has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for an investigational once-daily, single-tablet regimen combining…

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Study Reveals Growing Public Optimism for Scientific Breakthroughs Alongside Increasing Concerns About the Pace of Global Change

Study Reveals Growing Public Optimism for Scientific Breakthroughs Amid Increasing Concerns Over the Pace of Global Change A new global report developed by Leaps by Bayer in collaboration with Boston Consulting Group and Ipsos UK sheds fresh light on how…

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Samsung Bioepis and ATLATL Enter MoU to Advance Early-Stage Biotech Innovation Across Asia-Pacific

Samsung Bioepis and ATLATL Enter MoU to Advance Early-Stage Biotech Innovation Across Asia-Pacific Samsung Bioepis Co., Ltd. has entered into a strategic collaboration with ATLATL Innovation Center to strengthen early-stage biotechnology innovation across the Asia-Pacific region. The two organizations announced…

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Genexine’s First-in-Class SOX2 Degrader GX-BP1 Achieves Up to 96% Tumor Growth Inhibition and Prevents Regrowth in Preclinical Studies

Genexine’s First-in-Class SOX2 Degrader GX-BP1 Achieves Up to 96% Tumor Growth Inhibition and Prevents Regrowth in Preclinical Studies Genexine, Inc., a clinical-stage biotechnology firm focused on next-generation therapeutic platforms, has reported new preclinical findings for its innovative oncology candidate GX-BP1.…

Read MoreGenexine’s First-in-Class SOX2 Degrader GX-BP1 Achieves Up to 96% Tumor Growth Inhibition and Prevents Regrowth in Preclinical Studies

Saving Limbs Where Others Fail: Cagent Vascular Reports Landmark Data for Serration Remodeling Therapy™ in Below-the-Ankle Arteries

Advancing Limb Salvage: Cagent Vascular Reports Landmark Peer-Reviewed Evidence Supporting Serration Remodeling Therapy™ in Complex Below-the-Ankle Arteries Cagent Vascular, a recognized innovator in endovascular device technologies, has announced the publication of new peer-reviewed clinical evidence in the Journal of Endovascular…

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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…

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

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…

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