FDA grants fast track designation to TransThera Sciences experimental Phase 2 cholangiocarcinoma drug.
An FDA inspection leads to a 10-item Form FDA-483 issued to Innoveix Pharmaceuticals that took issue with the firms GMPs for sterile drug products.
FDA publishes a draft guidance on recommended documentation for premarket submissions of medical device software functions.
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.