Tag: Sotatercept

Acceleron Receives Orphan Designation from the European Commission (EC) for Sotatercept in Pulmonary Arterial Hypertension (PAH)

– Sotatercept received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) in PAH in 2019 – – In the spring of 2020, sotatercept received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), both in PAH – December 14, 2020 07:00 AM Eastern Standard […]

Acceleron Receives FDA Breakthrough Therapy Designation for Sotatercept in Pulmonary Arterial Hypertension

Sotatercept granted first FDA Breakthrough Therapy designation in pulmonary arterial hypertension since the Agency established the designation in 2012 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug […]