Federal Register notice: FDA seeks input and comments from interested stakeholders to help it establish strategic priorities for its Office of Minorit...
Aurobindo Pharma recalls one lot of mirtazapine due to a label error on declared strength.
FDA issues a guidance describing relevant information to be included in premarket submissions reporting non-clinical bench performance testing,
FDA publishes a guidance on its enforcement priorities for Electronic Nicotine Delivery System (vaping) products being marketed without FDA authorizat...
Neovasc files a PMA for its Neovasc Reducer for treating refractory angina.
Several drug companies raise prices on some 250 drugs for 2020.
Mesoblast files as part of a rolling BLA clinical efficacy and safety data for remestemcel-L, indicated for treating children with steroid-refractory ...
FDA approves the expanded use of Amarins Vascepas (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to statin therapy in adu...