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 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.
FDA approves a label update for Kites Yescarta to include the overall survival primary analysis from the landmark Phase 3 Zuma-7 study.
FDA warns Singapores Wipro Unza Singapore Private, Limited, about refusing to respond to two agency records requests for information on the firms manu...
FDA approves Ionis/AstraZenecas Wainua to treat adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis.
FDA warns Argentinas Terragene S.A. about Quality System violations in its manufacturing of Biological and Chemical Sterilization Process Indicator Sy...
