GlaxoSmithKline submits to FDA additional materials involving an assessment of its Zofran.
FDA accepts for review a Fresenius Kabi BLA for a pegfilgrastim biosimilar candidate (MSB11455) that references Amgens Neulasta.
FDA denies a Public Citizen petition asking it to revoke the PMA approval for Cyberonics Vagus Nerve Stimulation device for use in treating treatment-...
FDA says it will not object to some design or manufacturing modifications for devices approved through a PMA or HDE during the Covid-19 public health ...
FDA releases its latest batch of Warning Letters that includes Altaire Pharmaceuticals and Samchundang Pharm.
FDA clears a Smart Medical Systems 510(k) for the G-Eye Colonoscope.
FDA releases a draft ICU guideline of permitted daily exposure to three solvents.
FDA warns Altaire Pharmaceuticals about repeat CGMP violations in its manufacturing of finished drugs.