Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants.
A Kaiser Health News report posted online by NBC News raises questions about FDA approval of Janssens new depression drug Spravato.
FDA grants Genentech accelerated approval on a BLA for Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a ritu...
CDERs Office of Compliance sets up a new compounding team with responsibility for the overall management of the agencys drug compounding compliance pr...
Provention Bio says that a recent study showed that a single 14-day course of PRV-031 (teplizumab) significantly delayed the onset and diagnosis of cl...
Federal Register notice: FDA reopens the comment period on a 2/17 Federal Register notice entitled Quality Considerations for Continuous Manufacturing...
Federal Register notice: FDA announces an 11/18 The public workshop entitled Development of Best Practices in Physiologically Based Pharmacokinetic (P...
Federal Register notice: FDA submits to OMB an information collection extension for FDA Safety Labeling Change Implementation of Section 505(o)(4) of...