Medical Device | March 12, 2026
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 study hit its primary goal, showing a statistically significant rise in participants achieving EASI-75
The new equipment will be installed at Codis’ 400,000-square-foot Haverhill facility and is expected to be operational by 2027
The two companies will collaborate to evaluate Hopewell’s ttLNPs for clinical applications
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
Starting January 1, 2027, Lilly’s Zepbound (tirzepatide), Mounjaro (tirzepatide), and orforglipron, if approved, will be available through participating Medicare Part D plans
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