Zydus, a leading discovery based, global pharmaceutical company, announced that it has received permission from the US FDA to initiate the phase 2(b)/3 prospective, multi-centre, randomized, double-blind, placebo-controlled adaptive clinical trial to evaluate efficacy and safety of Saroglitazar magnesium in subjects with primary biliary cholangitis (PBC).
Cadila Healthcare on December 5 said it has filed the New Drug Application (NDA) of Saroglitazar Mg with the Drug Controller General of India (DCGI).