Drug Approval | December 11, 2025
Roche secures European nod for Gazyva/Gazyvaro in Lupus Nephritis patients
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
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
Roche says its new assay “resolves this challenge by delivering accurate and specific results
Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas
India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines
The agreement pairs Croda’s global footprint and “smart science” approach with Amino’s precision manufacturing capabilities
The partnership also allows both companies to explore CR-001 and SKB105 as monotherapies and in combination
Dr Reddy’s will pay Immutep US$ 20 million upfront and could deliver as much as US$ 349.5 million in regulatory and commercial milestones
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