Below are FDA's original approvals of NDAs and BLAs issued in the past week. Please see key below chart for a guide to frequently used abbreviations.
FDA's NDA And BLA Approvals: Kyleena, Exondys 51, Invokamet XR, Epaned
Below are FDA's original approvals of NDAs and BLAs issued in the past week. Please see key below chart for a guide to frequently used abbreviations.
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The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.
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Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.
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Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.