Drugs

FDA Approves Liquidia’s Pulmonary Hypertension Drug

FDA has approved Liquidia’s Yutrepia (Treprostinil), a new inhalation powder designed to treat adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Yutrepia is designed to “enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort,” the company says.

Approval was based on data from the Phase 3 INSPIRE trial, which evaluated Yutrepia in patients both new to and previously treated with nebulized treprostinil. The study demonstrated the drug to be safe and well-tolerated across both groups, according to Liquidia.

However, the launch of Yutrepia may face legal hurdles. United Therapeutics has filed a patent infringement lawsuit against Liquidia, seeking to block the commercial release of the drug. Oral arguments on a motion for a temporary restraining order and preliminary injunction were heard 5/20 in federal court, and a ruling is pending. Previously, FDA granted United Therapeutics an additional three-year exclusivity period for Tyvaso DPI (treprostinil), which blocked Liquidia’s Yutrepia from entering the market until today (5/23).

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome