The approval comes after a systematic review of published literature
The study hit its primary goal, showing a statistically significant rise in participants achieving EASI-75
Germany will be the first launch market
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
Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints
The trial met its primary endpoint, showing statistically significant improvements in Myasthenia Impairment Index (MGII) Patient-Reported Outcome (PRO) ocular scores at Week 4
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