Zydus Lifesciences Ltd News & Stock Insights Today

The study, known as EPICS-III, tested the drug in adults with primary biliary cholangitis (PBC) a rare, progressive liver disease that often leaves patients with limited treatment options.

The company said it will work with the US regulator to resolve the points raised as quickly as possible.

This development comes after a USFDA inspection at one of Zydus' oncology facilities earlier this year.

In its filing with the bourses, Zydus informed that these observations received were minor, and not related to data integrity.

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For Zydus, this clean report adds a layer of credibility to its US compliance track record especially since the Ankleshwar facility is a key site for its API exports.

The acquisition is priced at $7.50 per share and will be completed in cash within 60 days, subject to regulatory approvals

It provides benefits such as faster approval, priority review and a more open line of communication with the F.D.A.

They are the generic form of Absorica, a well-known prescription treatment for severe and hard to treat forms of nodular acne that the patient has not responded well to other treatments with.