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.
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...
An FDA inspection last month at Aurobindo Pharmas Telangana, India manufacturing facility leads to a nine-observation Form 483.
FDA clears a Masimo 510(k) for its O3 Regional Oximetry for use on neonatal and infant patients.
FDA grants Genentech accelerated approval on a BLA for Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a ritu...