The inspection concluded with one minor observation in Form 483
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The company will respond to the US FDA within the stipulated timelines
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
The company has unveiled the results of pirtobrutinib from its BRUIN CLL-313 study
The Phase 2 study tested two dose levels of pumitamig alongside four standard chemotherapy regimens across first
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