FDA nod to first treatment for rare genetic brain disorder
The approval comes after a systematic review of published literature
The approval comes after a systematic review of published literature
The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%
The initiative provides clearer regulatory guidance and a defined path from research in space to patient access on Earth
Germany will be the first launch market
Huwel’s diagnostic solutions leverage open RT-PCR system
The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials
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
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