Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold.
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Nordic Bioscience Gets FDA Letter of Support for CPa9-HNE Biomarker in IBD
The biomarker assay can be used potentially to enrich clinical trials and monitor patients' disease activity and treatment response.
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Risk of aspiration during surgery added to GLP-1 drug labels
From STAT’s Elaine Chen: Earlier this month, the FDA updated the labels of GLP-1 drugs to warn of the risk of patients ...
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FDA Extends Review of Tapinarof Cream for Atopic Dermatitis
The new PDUFA target date is March 12, 2025. The Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for tapinarof cream, 1% in the ...