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 approval comes after a systematic review of published literature
Phase I EPRAD study of DT-9081 demonstrated a favorable safety profile
The Hydrus Microstent stands out as the first and only MIGS device backed by five-year clinical outcomes
Giredestrant shows promise despite missing primary goal
The initiative provides clearer regulatory guidance and a defined path from research in space to patient access on Earth
Starting January 1, 2027, Lilly’s Zepbound (tirzepatide), Mounjaro (tirzepatide), and orforglipron, if approved, will be available through participating Medicare Part D plans
The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
The interim results of the Phase 3 SUCCESSOR-2 study's safety profile aligned with expectations for both mezigdomide and the combination regimen
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