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FDA posts answers to frequently asked questions about its new laboratory-developed test final rule.[ Price : $8.95]
Merck reports positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab in treating respira...[ Price : $8.95]
Experts from FDA and two other groups publish considerations for the use of overall survival as an endpoint in cancer clinical tri...[ Price : $8.95]
FDA accepts a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL, indicated for treating diabetic macular ed...[ Price : $8.95]
FDA clears a Think Surgical 510(k) for its Tmini Miniature Robotic System with Tmini 1.1. software for total knee arthroplasty pro...[ Price : $8.95]
FDA plans to ask an advisory committee 7/25 whether a new trial should be conducted before approving an AstraZeneca supplemental B...[ Price : $8.95]
FDA posts a draft guidance entitled Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products; Ques...[ Price : $8.95]
Federal Register notice: FDA corrects a 7/2 notice that announced the determination of the regulatory review period for Sanofis Xe...