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
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations
DiaMedica said it plans to launch the trial later in 2026
The company announced positive topline data from the Phase II ZUPREME-1 trial
Pivya is Alembic’s first branded pharmaceutica product in the US and is being marketed through Alembic Therapeutics LLC
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