FDA accepts for review a Y-mAbs Therapeutics BLA for Danyelza (naxitamab) for treating patients with relapsed/refractory high-risk neuroblastoma.
Federal Register notice: FDA announces a 6/17-18 Oncologic Drugs Advisory Committee meeting that will review four pediatric development plans.
FDA posts a guidance on institutional review board reviews of individual patient expanded access requests.
A BuzzFeed review of internal FDA documents finds the agency granted emergency use authorization for chloroquine and hydroxychloroquine to treat Covid...
Federal Register notice: FDA establishes a public docket to solicit comments on the agencys Approved Drug Products With Therapeutic Equivalence Evalua...
Medtronic recalls the auto-registration feature of its StealthStation Deep Brain Stimulation Software due to inaccuracies caused by minor patient move...
FDA commissioner Stephen Hahn says permanent procedural and policy changes will flow from the agency's Covid-19 response.
Federal Register notice: FDA establishes a docket to obtain information and comments from stakeholders about establishing a rare disease clinical tria...