Fresenius Kabi USA recalls one lot of ketorolac tromethamine injection, 30 mg/mL, 1 mL fill in a 2 mL amber vial, due to the presence of particulate m...
FDA accepts a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) for reducing the risk of cardiovascular death and hosp...
Boston Scientific recalls all unused inventory of its Lotus Edge Aortic Valve System due to complexities associated with the product delivery system....
Federal Register notice: FDA determines that 20 drug products were not withdrawn from sale for reasons of safety or effectiveness, which makes them av...
Federal Register notice: FDA reopens the comment period for a notice that appeared in the 7/31/2020 Federal Register in which FDA identified certain b...
FDA says that all 53 new molecular entity approvals in 2020 were acted on by or before their user fee goal dates.
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Recall Regulations 21 CFR Part 7.
FDA issues a clinical hold on a Neoleukin Therapeutics Phase1 clinical trial of its immunotherapeutic candidate, NL-201, requesting a new assay to mea...