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...
Federal Register notice: FDA issues an order permanently debarring Maria Anzures-Camarena from providing services related to an approved or pending dr...
Federal Register notice: FDA withdraws three NDAs from multiple applicants after they notified the agency that the products were no longer marketed....
FDA approves Amgens Bkemv as an interchangeable biosimilar for Alexions Soliris, indicated to treat two rare diseases.
Johnson & Johnson reports positive topline results from its pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant a...
