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Zydus Lifesciences' subsidiary presented Phase 2b trial data for investigational saroglitazar in MASH at AASLD 2026. The drug showed higher steatohepatitis resolution than placebo, but its safety and effectiveness for this use are not yet established.
Zydus Lifesciences presented post-hoc analysis from its EPICS-III clinical trial for Saroglitazar at ACG 2026. The drug remains under regulatory review for PBC treatment.
Zydus Lifesciences announced that a recent USFDA inspection of its pharmacovigilance and post-marketing surveillance system at the company’s USA office concluded with nil observations.
Zydus Lifesciences announced positive Phase II(b) clinical trial results for Saroglitazar Mg in MASH. The global study successfully met its primary endpoint of resolution of steatohepatitis.
Zydus Lifesciences received final USFDA approval for Ascorbic Acid Injection with 180-day exclusivity. The reference brand product had annual US sales of approximately USD 11.6 million.
Zydus Lifesciences' subsidiary, Sentynl Therapeutics, signed an option and license agreement with Mereo BioPharma for alvelestat. The deal includes upfront and R&D payments totaling 380 Crore.
Zydus Lifesciences received an Establishment Inspection Report (EIR) from the USFDA for its Ahmedabad injectable facility, with a 'Voluntary Action Indicated' (VAI) classification.
Zydus Lifesciences received approval for a Phase III clinical trial of Desidustat for Sickle Cell Disease. The trial is conducted in collaboration with ICMR.
Zydus Lifesciences submitted its Business Responsibility and Sustainability Report for FY 2025-26. The report details ESG metrics, workforce statistics, and CSR compliance for the period.
Zydus Lifesciences Limited announced the conclusion of a USFDA GMP surveillance inspection at its Ahmedabad Biologics Injectable plant. The inspection ended with seven observations and no data integrity issues. The company intends to work closely with the regulator to address these findings expeditiously.