FDA grants Arch Oncology an orphan drug designation for AO-176 and its use in treating relapsed/refractory multiple myeloma.
FDA issues Pfizer and OPKO Health a complete response letter for their BLA for somatrogon, an investigational once-weekly long-acting recombinant huma...
FDA launches a REMS Public Dashboard to improve data access and transparency.
Five stakeholders give FDA their recommendations for changes to its proposed rule to establish a regulatory category for OTC hearing aids.
Federal Register notice: FDA seeks comments on its proposal to classify human leukocyte antigen, human platelet antigen, and human neutrophil antigen ...
Federal Register notice: FDA classifies retinal diagnostic software devices into Class 2 (special controls).
FDA commissioner nominee Robert Califf says ways must be found to speed confirmatory trials for drugs given accelerated approval.
FDA places a clinical hold on Dyne Therapeutics IND for a trial of Dyne-251 to treat Duchenne muscular dystrophy.