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FDA publishes a guidance with recommendations for collecting a core set of patient-reported clinical outcomes in cancer clinical t...[ Price : $8.95]
FDA places a clinical hold on the Novavax IND for a Covid-19/influenza combination vaccine and influenza standalone vaccine follow...[ Price : $8.95]
FDA publishes a guidance reflecting GDUFA 3 provisions on the procedures for ANDA applicants to follow in requesting reconsiderati...[ Price : $8.95]
FDA clears a Bracco Diagnostics and Subtle Medical 510(k) for their artificial intelligence-powered software AiMify for brain MRIs...[ Price : $8.95]
Novocure wins PMA approval for Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for treating adult patients w...[ Price : $8.95]
The DC federal court rules in favor of FDA and MSN Pharmaceuticals as defendants in a suit filed by Novartis over the agencys appr...[ Price : $8.95]
FDA accepts for priority review a GSK NDA for gepotidacin, a first-in-class oral antibiotic for treating female adults and adolesc...[ Price : $8.95]
FDA commissioner Robert Califf and two colleagues discuss the agencys role in regulating artificial intelligence in biotechnology ...