News | December 13, 2025
Merck wins key EU backing to expand use of PAH Drug WINREVAIR
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
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
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas
Akero became a wholly owned subsidiary of Novo Nordisk
Zyrifa is indicated for patients with bone metastases stemming from a wide range of solid tumors
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