FDA nod to LifeVac De Novo, paving for next-generation anti-choking device
The FDA classified LifeVac as a Class II medical device
The FDA classified LifeVac as a Class II medical device
The trial met its primary endpoint, with patients receiving povetacicept achieving a 52.0% reduction in UPCR at Week 36
The MAST trial is designed to test whether a single dose of pre-emptive, orally administered EBX-102-02 can protect and restore microbial diversity during transplantation
Diasens and GlucoLive are designed for diabetic, Chronic Kidney Disease (CKD), and post-transplant patients who require continuous glycaemic surveillance and integrated remote care
The study hit its primary goal, showing a statistically significant rise in participants achieving EASI-75
Under the deal, Hims & Hers will offer patients access to FDA-approved versions of Ozempic and Wegovy at the same self-pay prices available through other telehealth platforms
The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
ABBV-295 produced clinically meaningful, dose-dependent weight loss over 12–13 weeks
DiaMedica said it plans to launch the trial later in 2026
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