Category Regulatory

Kidney Transplant

Kidney Transplant Eledon Pharma Highlights Tegoprubart in Second Pig Kidney Transplant to Human

Kidney Transplant Eledon Pharmaceuticals Advances Xenotransplantation with Tegoprubart Kidney Transplant Eledon Pharmaceuticals has announced that its investigational anti-CD40L antibody, tegoprubart, was a crucial component of the immunosuppression regimen used in a historic kidney xenotransplantation procedure. On January 25, 2025, a…

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Device

Onc.AI Secures FDA Breakthrough Device Designation for AI-Powered CT Response Model

Onc.AI Secures FDA Breakthrough Device Designation for AI-Powered CT Response Model Onc.AI, FDA a pioneering digital health company specializing in AI-driven oncology clinical management solutions, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Breakthrough…

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Fibromyalgia Treatment

Fibromyalgia Treatment Highmark Now Covers FDA-Cleared Fibromyalgia Treatment by Swing Therapeutics

Swing Therapeutics’ Stanza Receives Positive Coverage Decision from Highmark Health for Fibromyalgia Treatment In a major breakthrough for the treatment of fibromyalgia, Swing Therapeutics has announced that Stanza, its innovative digital therapeutic, has received a positive coverage decision from Highmark…

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Median Technologies

Median Technologies eyonis™ LCS Hits Primary Endpoint in RELIVE Trial, Final Step for Regulatory Submission

Median Technologies has announced a significant milestone in its mission to revolutionize lung cancer screening. The company’s proprietary artificial intelligence (AI) and machine learning (ML)-based software, eyonis™ Lung Cancer Screening (LCS), has successfully met the primary endpoint in the RELIVE…

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Sumitomo Pharma Reports TWYMEEG® Q4 2024 Sales and Full-Year Forecast in Japan

Poxel SA and Sumitomo Pharma: A Closer Look at TWYMEEG®’s Sales Performance and Strategic Growth Initiatives In the rapidly evolving landscape of metabolic disease treatments, Poxel SA (Euronext: POXEL – FR0012432516) stands out as a pioneering clinical-stage biopharmaceutical company. With…

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New Data Shows DCT Components Enhance Clinical Trial Access for Underrepresented Communities

New Study Shows DCT Components Boost Diversity, But Gaps Remain for Black Participants DCT Components, The lack of diversity in clinical trials has been a persistent issue, with racial, ethnic, and gender disparities often leaving underrepresented communities excluded from critical…

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ImmunityBio & BeiGene Launch Phase 3 Trial for ANKTIVA® and PD-1 Inhibitor in NSCLC

ImmunityBio, Inc. (NASDAQ: IBRX) has announced a strategic collaboration and supply agreement with BeiGene, Ltd. (soon to be renamed BeOne Medicines, Ltd.), a global oncology company. The partnership will focus on conducting a confirmatory, randomized Phase 3 clinical trial (ResQ201A-NSCLC),…

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