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Direct Biologics Announces FDA Authorization to Expand Ongoing Phase 3 Clinical Study of ExoFlo™ to All-Cause Moderate-to-Severe ARDS

Direct Biologics, LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles (EVs) secreted from bone marrow-derived mesenchymal stem cells to...

EVERSANA Announces Partnership with ChemoMouthpiece, LLC to Support U.S. Launch & Commercialization of Medical Device to Help Cancer Patients Manage and Treat Oral Mucositis

EVERSANA, a leading provider of commercialization services to the life science industry,  announced a partnership with ChemoMouthpiece, LLC to support the launch and commercialization...

BD Onclarity HPV Assay Receives FDA Approval for Use with Both BD SurePath Liquid-based Pap Test and Hologic ThinPrep Pap Test

BD, a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) market approval for the BD Onclarity HPV Assay to...

PathAI Announces Two New Executives to Expand Regulatory Expertise and Precision Oncology Commercial Strategy

PathAI, a leading provider of AI-powered pathology tools to advance precision medicine,  announced that Nick Anderson, Ph.D, has joined as Vice President of Regulatory...

ADDF Statement on FDA Decision Not to Grant Accelerated Approval to Donanemab for Treatment of Alzheimer’s Disease

Drugmaker Eli Lilly & Co announced that the FDA has issued a complete response letter, meaning it has not granted accelerated approval for amyloid-clearing...
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