Author Archives: Ashraf Malhas, PhD

FDA Declines SteadyMed’s New Drug Application for Trevyent, Delivered via PatchPump, to Treat PAH

The U.S. Food and Drug Administration (FDA) has declined SteadyMed Therapeutics‘ new drug application (NDA) for its Trevyent (treprostinil injection) therapy to treat pulmonary arterial hypertension (PAH). SteadyMed, with offices in San Ramon, California, and in Israel, had submitted its NDA in July 2017. But the application was denied on Aug. 31…