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FDA Updates Sotatercept Label, ERS Releases PAH Guidelines Based on HYPERION Data
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Fusion42 · 6 October 2026 · Fusion42 review
The FDA has updated the label for Sotatercept and the European Respiratory Society (ERS) has released new pulmonary arterial hypertension (PAH) guidelines based on data from the HYPERION study.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 22 Sep 2026 and 5 Oct 2026.
◆ ◆ The Wire takeaway
You face a clearer regulatory path with Sotatercept's updated FDA label and new ERS PAH guidelines, which could open market access and prescriber confidence if your biotech product targets pulmonary arterial hypertension.
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2 sources · first reported 22 Sep 2026 · latest 5 Oct 2026
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