Indian pharmaceutical company Lupin has announced its approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Obeticholic Acid Tablets, 5 mg and 10 mg. In March 2023, Lupin was issued tentative approval for Obeticholic Acid Tablets, 5 mg and 10 mg from the FDA. These tablets are […]
Aligos Therapeutics has stopped further development of ALG-010133, its STOPS drug candidate, in chronic hepatitis B (CHB) owing to futility. The California-based clinical stage biopharma company said that the decision has been driven by emerging data from the ALG-010133-101 phase 1 clinical trial that suggests there is no meaningful reduction of Hepatitis B surface antigen […]
Mirum Pharmaceuticals has secured the breakthrough therapy designation for maralixibat from the US Food and Drug Administration (FDA) for the treatment of pruritus associated with Alagille syndrome (ALGS) in patients, aged 1 year and older. The California-based biopharma company is engaged in the development and commercialization of new therapies for debilitating liver diseases. Alagille syndrome […]