NDA

January 21, 2019January 25, 2019

Actelion Needs Further Studies on Opsumit Treatment for Inoperable CTEPH, US FDA Says

CTEPH News, News

Actelion Pharmaceuticals has received a complete response letter from the U.S. Food and Drug Administration (FDA) specifying that the company needs to conduct further studies and obtain more data in order ... Read more

March 16, 2018March 16, 2018

Cardiome Shares Updates on Therapies, Including Trevyent for PAH

News, PAH News

Cardiome recently shared an update on the development of its therapeutic portfolio, including Trevyent (treprostinil injection) for the treatment of pulmonary arterial hypertension (PAH). Following the U.S. Food and Drug Administration’s ... Read more

December 13, 2017December 13, 2017

SteadyMed to Test Its PAH Therapy Delivery Device Further, at FDA’s Request

News

SteadyMed Therapeutics will do more testing to answer American regulators’ questions about the safety and effectiveness of its PatchPump pulmonary hypertension therapy delivery device. The U.S. Food and Drug Administration rejected ... Read more

September 5, 2017September 5, 2017

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

News, PAH News

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, ... Read more

July 7, 2017July 7, 2017

SteadyMed Submits New US Drug Application for PAH Treatment Trevyent

News, PAH News

SteadyMed Therapeutics submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Trevyent (treprostinil injection) in the treatment of pulmonary arterial hypertension (PAH), SteadyMed’s partner, Cardiome Pharma, recently announced. ... Read more

May 4, 2017May 4, 2017

SteadyMed’s PatchPump Infusion System for Trevyent Given US Patent

News, PAH News

SteadyMed announced it has received a U.S. patent for its PatchPump infusion system for injectable drugs, including Trevyent, the company’s lead candidate as a potential treatment for pulmonary arterial hypertension (PAH). The patent, issued ... Read more

April 21, 2017April 21, 2017

Patch That Will Deliver Pulmonary Hypertension Treatment Trevyent Is Effective, Study Shows

News, PAH News

The patch that delivers SteadyMed’s pulmonary arterial hypertension (PAH) treatment Trevyent (treprostinil) to patients is effective, safe and tolerable, according to a company study. Treprostinil is a vasodilatory prostacyclin analogue, or synthetic version of prostacyclin, ... Read more

September 8, 2016September 8, 2016

Potential PAH Therapy, Trevyent, Being Readied to Request FDA Approval

News

SteadyMed announced that it recently completed the manufacturing of required batches of its drug candidate Trevyent, designed to treat pulmonary arterial hypertension (PAH). The work will allow the company to evaluate the ... Read more

December 29, 2014October 22, 2015

Actelion Looks to Bring New PAH Drug to Market

News

Biopharmaceutical company and leader in pulmonary arterial hypertension (PAH) therapeutics, Actelion Ltd., has just announced it has filed a New Drug Application (NDA) with the US Food and Drug ... Read more

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