Citing safety concerns, Fresenius asked the FDA to withhold approval for an additional indication for Keryx’s sNDA for Auryxia. Source: Drug Industry Daily

An FDA advisory committee voted unanimously Wednesday in favor of the risk-benefit profile for Novartis’ BLA for an innovative new cancer therapy. Source: Drug Industry Daily

Officials from Kentucky, Maryland, Rhode Island and Virginia testified to a house committee yesterday about the opioid epidemic in their states and asked for more assistance to combat the problem.…

The House passed its version of the FDA user fee reauthorization package Wednesday that is expected to bring in $1.42 billion in fiscal 2018, by a voice vote. Source: Drug…

The House Appropriations Committee on Wednesday approved a bill by voice vote that would provide a total of $5.2 billion for the FDA in fiscal 2018—$2.6 billion in discretionary spending…