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
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
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
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
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
This collaboration sets the stage for WuXi Biologics’ first integrated CRDMO center in the region
The partnership also allows both companies to explore CR-001 and SKB105 as monotherapies and in combination
The study met its primary endpoint and all 11 secondary efficacy endpoints
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