Two drug company associations recommend changes to an FDA draft guidance on the content and format of labeling statements of ingredients in NDAs and A...
Magellan Diagnostics pleads guilty in federal court to criminal charges arising from its concealment of a device malfunction that produced inaccuratel...
J&J touts positive overall survival results of its Carvykti in a Phase 3 trial in patients with relapsed or lenalidomide-refractory multiple myeloma a...
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.