Wednesday, October 26, 2016
Serodus ASA Said on Tuesday Office of Orphan Products Development, United States Food and Drug Administration (FDA) has granted Orphan Drug Designation for SER100 in pulmonary arterial hypertension (PAH).
Subject to financing, Serodus will plan for first clinical study either in Phase IIa study or as adaptive Phase IIa/III (a combination of IIa and III) study in patients with PAH.
Source : reuters.com