FDA warns Royal Philips, based in the Netherlands, about multiple violations at two of its U.S. medical device manufacturing facilities and one in the...
Three Hyman, Phelps & McNamara attorneys notice that FDA has provided a 30-day response time instead of the usual 15 days for two medical device compa...
FDA sends Regeneron a complete response letter for its pre-filled Eylea HD syringe supplemental BLA, citing unresolved inspection findings at third-pa...
FDA warns Innocore Sales & Marketing in Woodstock, Ontario, Canada, about CGMP violations in its production of finished drugs.
FDA publishes a draft guidance with its recommendations for menstrual product performance testing and labeling.
Unicycive says it plans to resubmit its NDA for oxylanthanum carbonate to treat hyperphosphatemia before the end of this year.
FDA grants Revolution Medicines an orphan drug designation for its investigational therapy daraxonrasib for treating pancreatic cancer.
FDA names acting Office of New Drugs (OND) director Mary Tran Thanh-Hai as the new OND director, replacing previous head Peter Stein.
