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...
The American Clinical Laboratory Association and HealthTrackRX sue FDA to block the agencys final rule asserting authority over laboratory-developed t...
FDA grants Eli Lilly accelerated approval for Retevmo (selpercatinib) for pediatric patients two years of age and older with advanced or metastatic me...
