Category Regulatory

Satellite Bio Secures U.S. Food and Drug Administration Rare Pediatric Disease Designation for SB-101 in Urea Cycle Disorders

Satellite Bio Secures U.S. Food and Drug Administration Rare Pediatric Disease Designation for SB-101 in Urea Cycle Disorders Satellite Biosciences has announced a significant regulatory milestone, revealing that the U.S. Food and Drug Administration has granted Rare Pediatric Disease (RPD)…

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Canadian Association of Optometrists Marks Vision Health Month with “GetEyeWise” Online Campaign

Canadian Association of Optometrists Marks Vision Health Month with “GetEyeWise” Digital Awareness Campaign The Canadian Association of Optometrists is once again placing eye health in the national spotlight through its annual public education initiative, encouraging Canadians to take a closer…

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Corcept’s Phase 2 Trial of Dazucorilant Shows Two-Year Survival Advantage in Amyotrophic Lateral Sclerosis Patients

Corcept’s Phase 2 Trial of Dazucorilant Shows Sustained Two-Year Survival Advantage in ALS Patients Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage biopharmaceutical company focused on developing therapies that modulate cortisol activity, has reported new long-term data from its Phase 2…

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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…

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

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…

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