FDA slaps a clinical hold a Translate Bio IND submission for MRT5201 for treating ornithine transcarbamylase deficiency, due to additional clinical an...
FDA clears a United Imaging 510(k) for the uExplorer total-body scanner, which is described as the worlds first medical imaging scanner that can captu...
Janssen Biotech files the first part of a supplemental BLA for a label expansion to include the use of Darzalex (daratumumab) in combination with lena...
FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 8 to 8 on whether to recommend approval for Lexicon Pharmaceuticals Inc and Sanofis s...
FDA issues a guidance to help drug and biological product applicants develop the Indications and Usage section of labeling for products approved under...
FDA releases a draft International Council for Harmonization guidance on nonclinical safety testing of pediatric drugs.
FDA releases a guidance explaining the agencys Safety and Performance Based Pathway as an alternative approach for 510(k) submissions.
Attorney Mark Schwartz explores enforcement options open to FDA following expiration of the enforcement discretion period for stem cell facilities it ...