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The CDER Biomarker Qualification Program says it supports four pancreatic injury microRNA biomarkers identified and evaluated by t...[ Price : $8.95]
Two Sheppard Mullin attorneys describe FDAs latest effort to improve written patient-facing drug safety and efficacy information.[ Price : $8.95]
2seventy bio says its Seattle Childrens partner has paused a Phase 1 pediatric acute myeloid leukemia trial following a patient fa...[ Price : $8.95]
FDA approves an Amneal Pharmaceuticals 505(b)(2) for Pemrydi RTU, a ready-to-use version of pemetrexed for injection.[ Price : $8.95]
FDA gives Starton Therapeutics the green light to proceed with a Phase 1b clinical trial of its Star-LLD investigational continuou...[ Price : $8.95]
NeuroOne Medical Technologies files a 510(k) for its OneRF Ablation System.[ Price : $8.95]
FDA publishes a guidance on recommended content of premarket submissions for software contained in medical devices.[ Price : $8.95]
FDA warns Hauppauge, NY-based A&Z Pharmaceutical about illegally marketing an unapproved childrens calcium drug.