Drugs

MannKind sNDA for Rapid-Acting Furoscix Autoinjector

FDA has accepted for review a MannKind supplemental NDA for its Furoscix ReadyFlow autoinjector, a fast-acting device designed to treat edema in adults with chronic heart failure or chronic kidney disease. The agency has set a user fee review action target date of 7/26/2026.

The ReadyFlow autoinjector is intended to deliver an intravenous-equivalent 80 mg/mL dose of subcutaneous furosemide in under 10 seconds, a major speed increase compared to the currently FDA-approved Furoscix on-body infusor, which delivers the same therapy over about five hours. MannKind says the new device could allow patients to treat episodes of fluid buildup at home more quickly and conveniently, reducing hospital admissions and overall healthcare costs.

The submission is supported by a 2024 open-label crossover study of 21 healthy volunteers in which ReadyFlow’s subcutaneous furosemide achieved 107% relative bioavailability compared with IV administration — well within FDA’s required equivalence range of 80–125%, the company says. Participants also showed similar urine output and electrolyte excretion at 6, 8, and 12 hours. The autoinjector was generally well tolerated, with injection-site pain reported as the primary adverse effect, it adds.

Furosemide, a loop diuretic, carries known risks including electrolyte abnormalities, dehydration, ototoxicity, and, in patients with urinary obstruction, the potential for acute urinary retention, MannKind says.

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

Read more

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