FDA clears a Nitiloop 510(k) for its NovaCross CTO Microcatheter and its use in intraluminal placement of conventional and steerable guidewires beyond...
FDA releases its latest batch of Warning Letters that includes Global Treat Srl, Mandelay Kft and Philip Kennedy.
Federal Register notice: FDA corrects a 1/8 Federal Register notice that announced the withdrawal 23 ANDAs.
FDA approves a Bristol Myers Squibb and Acceleron Pharma BLA for Reblozyl (luspatercept-aamt) for treating anemia after failing an erythropoiesis stim...
Former FDA commissioner Scott Gottlieb weighs in on hydroxychloroquine for treating coronavirus and what he sees as the better potential of antiviral ...
A new Government Accountability Act report examines 637 NDAs submitted between 2014 to 2018 and found that review times were mainly driven by the char...
Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for the Collection of Qualitative Feedback on...
Federal Register notice: FDA sends to OMB an information collection extension for Human Cells, Tissues, and Cellular and Tissue-Based Products: Establ...