FDA posts a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 8.
FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Supplies outsourcing f...
FDA issues Rocket Pharmaceuticals a complete response letter on its BLA for gene therapy Kresladi (marnetegragene autotemcel; marne-cel) for treating ...
FDA approves a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer.
Johnson & Johnson reports positive data from its Phase 3 Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis.
The Biosimilars Council and Biosimilars Forum praise a revised FDA draft guidance on biosimilar promotional labeling.
FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery performance in device...
