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FDA clears a Nines 510(k) for the NinesMeasure, a lung nodule measurement tool built with artificial intelligence that is intended...[ Price : $8.95]
FDA warns Tarmac Products about multiple drug and medical device violations in its production of OTC drugs and wound dressing medi...[ Price : $8.95]
Four stakeholders suggest ways FDA can improve an upcoming public workshop on disease progression models.[ Price : $8.95]
FDA accepts for review an AbbVie NDA for atogepant, an orally administered calcitonin gene-related peptide receptor antagonist for...[ Price : $8.95]
FDA approves a four-year clinical trial using CRISPR gene editing to cure sickle cell disease.[ Price : $8.95]
Panelists at a conference debate the value of clinical efficacy studies to determine biosimilar bioequivalence.[ Price : $8.95]
Akebia Therapeutics submits an NDA for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor f...[ Price : $8.95]
HHS publishes its semiannual regulatory agenda including six final rules and four completed actions from FDA.