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FDA warns Chinas Qinjiang Kingphar Medical Material Co. about Quality System violations in its production of several medical devic...[ Price : $8.95]
FDA sends Regeneron a complete response letter for its pre-filled Eylea HD syringe supplemental BLA, citing unresolved inspection ...[ Price : $8.95]
FDA warns Royal Philips, based in the Netherlands, about multiple violations at two of its U.S. medical device manufacturing facil...[ Price : $8.95]
Unicycive says it plans to resubmit its NDA for oxylanthanum carbonate to treat hyperphosphatemia before the end of this year.[ Price : $8.95]
FDA grants Revolution Medicines an orphan drug designation for its investigational therapy daraxonrasib for treating pancreatic ca...[ Price : $8.95]
FDA warns Innocore Sales & Marketing in Woodstock, Ontario, Canada, about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA names acting Office of New Drugs (OND) director Mary Tran Thanh-Hai as the new OND director, replacing previous head Peter Ste...[ Price : $8.95]
Three Hyman, Phelps & McNamara attorneys notice that FDA has provided a 30-day response time instead of the usual 15 days for two ...