[ Price : $8.95]
FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren propose a digital health Center of Excellence.[ Price : $8.95]
FDA releases the FDA-483 with five observations from an inspection at Indias Live Pharmaceuticals.[ Price : $8.95]
FDA accepts for review a Sanofi and Regeneron Pharmaceuticals supplemental BLA for Praluent (alirocumab) to update the Prescribing...[ Price : $8.95]
FDA grants Syntimmune an orphan drug designation for SYNT001 for treating pemphigus.[ Price : $8.95]
FDA accepts for priority review a supplemental BLA for Keytruda, an anti-PD-1 therapy, as monotherapy for first-line treatment of ...[ Price : $8.95]
FDA publishes a guidance recommending technical specifications and general considerations for submitting certain ANDA comparative ...[ Price : $8.95]
A Tufts Center for the Study of Drug Development analysis shows that central nervous system drugs take longer to develop and appro...[ Price : $8.95]
FDA warns two Medtronic manufacturing facilities about Quality System violations in their production of cardiac medical devices.