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…
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…
DNAnexus Expands Relationship with Veeva to Advance Global Regulatory Collaboration DNAnexus, a global leader in regulatory cloud services, has announced the expansion of its collaboration with Veeva Systems, a prominent provider of cloud-based software for the life sciences industry. This…
Bayer has officially submitted a marketing authorization application to the European Medicines Agency (EMA), seeking approval for the use of finerenone in adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of 40% or greater. This…
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…
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…
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…
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),…
Arizona ADHD Center Expands with New Scottsdale Clinic, Enhancing ADHD Diagnosis and Treatment Arizona ADHD Center, a premier medical and behavioral health clinic specializing in ADHD diagnosis, treatment, and ongoing management, is proud to announce the opening of its new…
Roche Receives FDA Clearance for CLIA-Waived STI Point-of-Care Tests Roche has announced a major milestone in the realm of sexual health diagnostics. The U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance and Clinical Laboratory Improvement Amendments…
Eli Lilly and Company has announced that the U.S. FDA has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. This approval marks a significant milestone for the company, as Omvoh is now approved…
Incyte and Syndax Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approval of Niktimvo™ (axatilimab-csfr) in 9 mg and 22 mg vial sizes. The companies expect the product to be available for order in the United States by early…