Zydus Lifesciences Business Update
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.
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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.