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Changes to the Mavyret Product Label for Pediatrics
June 16, 2021The 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 ... -
FDA Clears LPCN 1148 IND Application for Phase 2 Cirrhosis Trial
May 06, 2020Lipocine 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 Expands NASH Trial to Include Cohort of Cirrhotic Patients
January 19, 2020Akero 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.
Pharma Sources Insight January 2025
