Drugs

Liquidia Sues FDA Over Tyvaso’s Exclusivity

Liquidia Corp. has filed a lawsuit against FDA over the agency’s recent decision to grant United Therapeutics Corp. (UTC) an additional three-year exclusivity period for Tyvaso DPI (treprostinil), which blocks Liquidia’s Yutrepia (treprostinil) from entering the market before 5/23/2025. Treprostinil is indicated for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

“FDA’s action is contrary to law and arbitrary and capricious,” the complaint says. “It improperly allows UTC to maintain its decades-long monopoly in violation of clear congressional intent permitting exclusivity only in strictly limited circumstances involving innovation. FDA exceeded its statutory mandate by improperly crediting a single study that fails to justify any exclusivity at all, and by granting UTC broad exclusivity for far more than the ‘innovation’ the study purportedly covered, encompassing unstudied indications, patient populations, drug-device combination products, and formulations.”

The complaint asks that FDA’s exclusivity decision be vacated, and that final approval be granted for Liquidia’s Yutrepia, which currently sits as being tentatively approved.

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