News | December 12, 2025
Granules Life Sciences facility receives EIR from USFDA
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
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
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