A Friends of Cancer Research working group white paper makes the case for seamless clinical trials for rare cancers.
FDA proposes a major shift in how biosimilars are evaluated, signaling that many products may no longer need traditional comparative clinical efficacy...
FDA grants Revolution Medicines an orphan drug designation for its investigational therapy daraxonrasib for treating pancreatic cancer.
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 Royal Philips, based in the Netherlands, about multiple violations at two of its U.S. medical device manufacturing facilities and one in the...
Unicycive says it plans to resubmit its NDA for oxylanthanum carbonate to treat hyperphosphatemia before the end of this year.
FDA warns Innocore Sales & Marketing in Woodstock, Ontario, Canada, about CGMP violations in its production of finished drugs.
FDA names acting Office of New Drugs (OND) director Mary Tran Thanh-Hai as the new OND director, replacing previous head Peter Stein.
