FDA denies an 8/2017 Allergan petition asking it to refuse to approve any pending ANDA for cyclosporine ophthalmic emulsion for which its Restasis is ...
FDA releases a draft guidance and Manual of Policies and Procedures intended to stream generic drug reviews and reduce the number of review cycles dru...
A new HHS Office of Inspector General report finds that from 2012 to 2016 Medicaid may have lost $1.3 billion in base and inflation-adjusted rebates f...
Clinical trial data integrator Datavant appoints former FDA chief information officer Eric Perakslis as its chief scientific officer.
PharMEDium Services recalls several lots of drug products to the hospital/user level due to a lack of sterility assurance.
Federal Register notice: FDA announces a joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory ...
Federal Register notice: FDA issues a priority review voucher to Spark Therapeutics for gaining BLA approval of Luxturna (voretigene neparvovec), an a...
FDA releases the FDA-483 issued following an October 2017 inspection at the KRS Global Biotechnology outsourcing facility.