FDA alerts healthcare providers to not purchase or implant Synovos Total Hip System because modifications to the original device design were not clear...
Invivyd seeks FDA emergency use authorization for VYD222, which is described as a broadly neutralizing, half-life extended monoclonal antibody candida...
FDA warns Solna, Sweden-based Sonesta Medical about Quality System violations in its manufacturing of three medical devices.
FDA publishes a guidance with recommendations on using digital health technologies for remote data acquisition.
FDA publishes a guidance to assist sponsors in seeking approval of new animal drugs for minor uses or minor species.
FDA requires an additional postmarketing confirmatory study for full approval of Amgens Lumakras non-small cell lung cancer treatment that obtained ac...
FDA approves Arcutis Biotherapeutics Zoryve topical foam to treat seborrheic dermatitis in individuals aged nine and older.
FDA issues a complete response letter for Zealand Pharmas dasiglucagon based on deficiencies at a third-party manufacturing facility.
