FDA medical reviewers question the effectiveness and safety of Sareptas SRP-9001 as a treatment for some cases of Duchenne muscular dystrophy and ask ...
Three congressional Democrats introduce legislation to require drug companies to accurately account for how much they spend on drug research and devel...
FDA clears the Apyx Renuvion/J-Plasma handpiece for coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.
FDA approves a Chiesi Global Rare Diseases and Protalix BioTherapeutics BLA for Elfabrio (pegunigalsidase alfa-iwxj) for treating adult patients with ...
An FDA advisory committee recommends the approval of a Laboratoire HRA Pharma NDA seeking a prescription-to-nonprescription switch of its Opill, a nor...
FDA clears a Hubly Surgical 510(k) for the Hubly Drill and its use in performing burr hole procedures as part of brain surgery.
FDA announces a joint project with the National Institute of Standards and Technology to develop resources needed by animal biotechnology developers.
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Somscans Detectnet (copper Cu-64 dotatate...
