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 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
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
This strategic investment aims to bolster the company's position as a global leader in Vitamin D3 manufacturing
It's a development that marks a potential breakthrough for people living with the rare and debilitating disease Duchenne muscular dystrophy (DMD)
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
Expands bioprocessing footprint across Asia
This collaboration sets the stage for WuXi Biologics’ first integrated CRDMO center in the region
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