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
The FDA aims to make a decision by April 8, 2026
The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics
At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
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
The new site will produce next-generation synthetic medicine active pharmaceutical ingredients
The new site marks the company’s first operation in the region
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