FDA approves Bristol Myers Squibbs Breyanzi (lisocabtagene maraleucel; liso-cel) for treating adult patients with relapsed or refractory mantle cell l...
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with chemotherapy for the first-line metastatic m...
Attorney James Beck says the 5th Circuit Court of Appeals made defense-friendly decisions in reversing several errors made by a Louisiana federal cour...
FDA denies a 2019 Novartis petition asking for specific requirements for ANDA applicants citing Entresto as the reference-listed drug.
OptumHealth Care Solutions recalls (Class 1) its Nimbus II Plus infusion pumps due to multiple potential failure modes that may include battery failur...
FDA says an agency reorganization changing the operation of the Office of Regulatory Affairs is scheduled to take effect 10/1.
CDER Office of Medical Policy director Khair ElZarrad uses a podcast to discuss the benefits and challenges of using artificial intelligence in drug d...
CDER posts a list of 10 things it says people should know about the Centers pharmaceutical quality function.
