FDA approves a new indication for Astellas VESIcare in an oral suspension to treat a type of bladder dysfunction in pediatric patients over age two.
FDA denies a petition asking it to investigate and take enforcement action against Edwards Lifesciences for marketing an annuloplasty ring without 510...
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.