FDA approves Fresenius Kabi and Formycons biosimilar Otulfi (ustekinumab-aauz), a copy of Johnson & Johnsons referenced Stelara.
Sen Bill Cassidy asks FDA to respond to questions about its decades-long failure to give Orange Book patent listing clarity to drug/device combination...
FDA warns East Rutherford, NJ-based Diamond Chemical about CGMP violations in the production of finished drugs.
FDA begins implementing a new model for FDA inspections as part of an agency-wide reorganization that was brought on by the 2022 infant formula debacl...
The CDER Office of Prescription Drug Promotion says it will research how using an endorser to provide prescription drug information in a health-themed...
Federal Register notice: FDA sends to OMB an information collection extension entitled Electronic User Fee Payment Request Forms Form FDA 3913 and Fo...
After four deaths were reported, Kezar Life Sciences suspends the enrollment of new patients and dosing of ongoing patients in its lupus nephritis Pha...
Federal Register notice: FDA makes available four final device-specific guidance documents for the Safety and Performance Based Pathway.
