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FDA accepts for priority review a Genentech sBLA for a new indication for its Tecentriq.[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Aspire Bariatrics medical d...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Synergy Pharmaceuticals Tru...[ Price : $8.95]
FDA determines for patent extension purposes the regulatory review period for Intercept Pharmaceuticals Ocaliva (obeticholic acid)...[ Price : $8.95]
FDA warns MiBo Medical Group about Quality System violations in its manufacturing of the MiBo Thermoflo.[ Price : $8.95]
FDA warns Koreas Barox about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA says its recognition of the ClinGen genetic data database will help speed development of novel diagnostic technologies to diag...[ Price : $8.95]
FDA says its researchers are evaluating a way to use mass spectrometry in drug quality control.