FDA principal deputy commissioner Amy Abernathy says the agency will announce within a month a plan to modernize its information technology approach f...
Janssen Pharmaceutical files a supplemental BLA for Tremfya (guselkumab) for treating adult patients with active psoriatic arthritis.
FDA posts a Form FDA-483 citing Hybrid Pharma (Deerfield Beach, FL) for significant GMP violations documented during a June inspection of the drug out...
Federal Register notice: FDA seeks comments on a petition requesting exemption from the premarket notification requirements for powered wheeled stretc...
Federal Register notice: FDA withdraws approval of an Impax ANDA for ursodiol capsules (XXX INSERT XXX)USP, 300 mg, due to agency concerns about the v...
Former FDA Commissioner Scott Gottlieb joins FasterCures advisory board.
FDA clears a Zimmer Biomet Holdings 510(k) for the JuggerStitch meniscal repair device.