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 Healey ALS Platform Trial is a multicenter, double-blind, placebo-controlled
The FDA aims to make a decision by April 8, 2026
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
Roche says its new assay “resolves this challenge by delivering accurate and specific results
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 new site will produce next-generation synthetic medicine active pharmaceutical ingredients
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