Merry Christmas From the FDA

I see that the FDA is in the holiday spirit - they've told Ariad that they can bring Iclusig back to the market in the US, subject to restrictions, and Amarin, who have been trying, quite unsuccessfully, to get approval for wide use of a fish-oil-pill, have at least gotten a stay of execution for now. And in what is a real surprise, United Therapeutics got approval for an oral version of treprostinil, a synthetic prostaglandin analog, for PAH. Since they'd been turned down twice before on that one, I don't think anyone anticipated that one, since it hadn't looked too impressive in the clinic.

Source: In the Pipeline - December 23, 2013 Category: Chemists Tags: Regulatory Affairs Source Type: blogs