Drug Approval | December 12, 2025
Apitoria Pharma receives 3 observations from USFDA for Unit-V
The company will respond to the US FDA within the stipulated timelines
The company will respond to the US FDA within the stipulated timelines
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification
The companies aim to expand treatment options for millions living with metabolic disorders
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
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
Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas
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