The positive CHMP opinion is supported by results from the Phase III QUASAR trial
Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
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 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
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
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
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