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Zydus announces EPICS-IIITM phase-II(b)/III adaptive pivotal clinical trial of Saroglitazar Mg in PBC expresspharma
December 10, 2021
Positive results from the phase-II(a) clinical trial evaluating Saroglitazar Mg in patients with NASH were published in the Journal of Hepatology.
EMA grants Orphan Drug Designation to Saroglitazar Mg for treating patients with PBC expresspharma
July 22, 2021
Zydus announced that the European Medicines Agency (EMA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC).
US FDA grants Orphan Drug Designation to Zydus’ Saroglitazar for primary biliary cholangitis treatment expresspharma
January 29, 2021
This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020.
USFDA grants Zydus fast track designation for Saroglitazar to treat primary biliary cholangitis expresspharma
December 10, 2020
Zydus announced that the United States Food and Drug Administration (USFDA) has granted ‘Fast Track Designation’ to Saroglitazar Mg for the treatment of patients with primary biliary cholangitis (PBC).
Zydus’ saroglitazar becomes first NASH drug approved globally pharmaceutical-technology
March 09, 2020
The Drug Controller General of India has approved Zydus’ saroglitazar for non-cirrhotic non-alcoholic steatohepatitis (NASH).