FDA says it is evaluating a DC federal court ruling remanding to the agency its memorandum of understanding with states on the interstate distribution...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novartis Adakveo (crizanlizumab-tmca).
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sanofis Dengvaxia (dengue tetravalent vaccine, ...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Galdermas Aklief (trifarotene), indicated for t...
FDA approves Insightecs Exablate Neuro for a third indication.
FDA grants breakthrough device designation for TecTraums Pro2cool system to improve concussion outcomes.
A BMJ investigation says a Ventavia Research Group whistleblower informed FDA about multiple irregularities in the companys work testing the Pfizer Co...
FDA chief scientist and Public Health Service Commissioned Corps rear admiral Denise Hinton leaves the agency FDA to serve as deputy Surgeon General.