the United States Food and Drug Administration (FDA) has approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity.
I originally thought the monotherapy had 50/50 chance of approval but this is a surprise after the FDA initial response seemed to imply new trials with among other things a fixed dose (which made little sense). I guess FDA is in a Christmas spirit after all... Who is next?
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