Federal Register notice: FDA permanently debars Duniel Tejeda from providing services in any capacity to a person that has an approved or pending drug...
The Senate Appropriations Committee posts its fiscal year 2023 proposed budget bill for FDA that increases the agencys spending by $229 million (7%), ...
An Amgen study says the FDA accelerated approval program is working well and should not be changed because there are some drug outliers in the program...
Jones Day attorneys update FDAs commitments for a regulatory framework to address artificial intelligence as a tool for advancing medical therapeutics...
FDA clears a bioMrieux 510(k) for its Vidas Nephrocheck assay to detect kidney stress in patients at risk of acute kidney injury.
FDA accepts for priority review a Gamida Cell BLA for omidubicel for treating patients with blood cancers in need of an allogenic hematopoietic stem c...
FDA publishes 48 new and revised product-specific guidances in its latest batch.
Federal Register notice: FDA withdraws the approval of seven ANDAs from multiple applicants after they notified the agency that the drugs are no longe...