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...
FDA warns Avcilar/Istanbul, Turkey-based Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi about CGMP violations in its production o...
FDA warns Anish Shah, doing business as Siyan Clinical Research in Santa Rosa, CA, about not following the investigational plan for a clinical investi...
