News | December 12, 2025
FDA fast-tracks first drug nod under new national priority voucher program
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
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
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
This strategic investment aims to bolster the company's position as a global leader in Vitamin D3 manufacturing
The new site marks the company’s first operation in the region
Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories
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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