FDA accepts for review a Sanofi and Regeneron Pharmaceuticals supplemental BLA for Praluent (alirocumab) to update the Prescribing Information to incl...
FDA grants Syntimmune an orphan drug designation for SYNT001 for treating pemphigus.
FDA accepts for priority review a supplemental BLA for Keytruda, an anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or ...
FDA publishes a guidance recommending technical specifications and general considerations for submitting certain ANDA comparative clinical endpoint bi...
A Tufts Center for the Study of Drug Development analysis shows that central nervous system drugs take longer to develop and approve than drugs in oth...
FDA warns two Medtronic manufacturing facilities about Quality System violations in their production of cardiac medical devices.
The HHS Inspector General outlines steps FDA could take to better integrate cybersecurity concerns into its medical device reviews before granting mar...
Federal Register notice: FDA announces a 10/11 Anesthetic and Analgesic Drug Products Advisory Committee meeting.