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The FDA has approved Mavyret (glecaprevir and pibrentasvir) oral pellets (100mg/40mg) for the treatment of pediatric patients 3 to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection ...
Lipocine announced that the U.S. Food & Drug Administration (FDA) has accepted the Company's Investigational New Drug application (IND) to initiate a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148.
Akero Therapeutics announced the ongoing Phase 2a BALANCED study of AKR-001 is being expanded to include an additional cohort of subjects with non-alcoholic steatohepatitis (NASH) who have compensated cirrhosis (F4), Child-Pugh Class A.