FDA clears an Intellijoint Surgical 510(k) for the intellijoint Hip Anterior, a 3D mini-optical navigation solution that provides quantifiable, intrao...
FDA grants DynPort Vaccine Co. an orphan drug designation for a plague vaccine being developed on behalf of the Defense Department.
In response to criticism of a Republican bill to replace ObamaCare, president Trump tweets his intention to formulate a plan to lower drug prices thro...
HHS secretary Tom Price hints that an FDA commissioner nomination could be announced as early as this week.
FDAs Chicago District Office says India-based Wockhardt now has seven of its 12 drug manufacturing facilities out of compliance with CGMPs.
FDA warns Indias Megafine Pharma about CGMP deviations and data integrity violations in its manufacturing of drugs.
FDA releases its latest batch of Warning Letters that cite Denttio, Megafine Pharma and Morton Grove Pharmaceuticals.
Recordati Rare Diseases asks FDA to require ANDA applications referencing its NeoProfen to take steps to mitigate the risk of precipitate formation.