FDA accepts for priority review a Genentech sBLA for a new indication for its Tecentriq.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Aspire Bariatrics medical device Aspire Assist....
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Synergy Pharmaceuticals Trulance (plecanatide)....
FDA determines for patent extension purposes the regulatory review period for Intercept Pharmaceuticals Ocaliva (obeticholic acid).
FDA warns MiBo Medical Group about Quality System violations in its manufacturing of the MiBo Thermoflo.
FDA warns Koreas Barox about CGMP violations in its production of finished drugs.
FDA says its recognition of the ClinGen genetic data database will help speed development of novel diagnostic technologies to diagnose diseases and gu...
FDA says its researchers are evaluating a way to use mass spectrometry in drug quality control.