FDA releases an FDA-483 with five observations from a 2017 inspection at Exela Pharma Sciences, an outsourcing facility.
Public Citizen calls on FDA to order withdrawal of Takedas Uloric from the market due to what it says is an unacceptable risk of death.
FDA grants Revive Therapeutics an orphan drug designation for cannabidiol for treating autoimmune hepatitis, a rare disease that causes inflammation t...
Federal Register notice: FDA files for OMB approval a proposed information extension for State Enforcement Notifications.
Global Blood Therapeutics say it is in discussions with FDA about accelerated approval for its voxelotor to treat sickle cell anemia based on partial ...
FDA approves an Achaogen NDA for Zemdri (plazomicin) for adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by ...
FDA warns Chinas Henan Lihua Pharmaceutical about significant deviations in its production of active pharmaceutical ingredients at two facilities.
FDA accepts for priority review a Genentech NDA for baloxavir marboxil, a single-dose, oral treatment for acute, uncomplicated influenza in people 12 ...