Bipartisan House members introduce legislation they say will lower insulin costs.
CDER approves 48 new molecular entities in 2019, which is 20% below last years record 59 submissions.
LivaNova recalls (Class 1) its VNS Therapy SenTiva Generator System due to an unintended reset error that causes the system to stop delivering therapy...
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.