Andrew Cox, Pharm.D., MBA

Just over half (51%) of patients who treated with the experimental agent, called elafibranor, achieved a biochemical response compared with only 4% of those patients randomly assigned to placebo.

The same adjuvant is part of Shingrix, the shingles vaccine.

The FDA has set March 24, 2024, as PDUFA date for the drug.

Researchers at the University of California, San Francisco, report positive results from the No One Waits study.

Capsid assembly modulators (CAM) work by assembling flawed hepatitis B capsids and preventing the formation of new infectious viruses.

Gilead’s hepatitis D antiviral, bulevirtide, was dealt a setback last year when the FDA issued a complete response letter. Positive results from a phase 3 trial of bulevirtide, were reported in July.

To add precision to the nomenclature and nosology and remove stigma, experts are moving to rename nonalcoholic fatty liver disease as metabolic dysfunction-associated steatotic liver disease.

Based on the results published in the New England Journal of Medicine, the FDA has granted breakthrough status to the FGF21 analogue. The drug's maker is planning a phase 3 trial.