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FDA grants Novartis accelerated approval for Tafinlar (dabrafenib) plus Mekinist (trametinib) for treating certain patients six ye...[ Price : $8.95]
FDA publishes a guidance on clinical pharmacology considerations in assessing food effects in INDs and NDAs.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Improving Communication of Important S...[ Price : $8.95]
FDA publishes a draft guidance explaining how it periodically assesses drugs that have been granted breakthrough therapy designati...[ Price : $8.95]
University of Illinois psychiatry professor Anand Kumar calls on FDA to closely reevaluate the accelerated approval program to be ...[ Price : $8.95]
Medtronic recalls (Class 1) one lot of batteries for its HeartWare Ventricular Assist Device due to welding defects that allow sep...[ Price : $8.95]
The House Appropriations Committee votes 31 to 26 to approve an FDA spending bill for fiscal year 2023 that will boost the agencys...[ Price : $8.95]
FDA clears the Medtronic LigaPASS ligament augmentation system.