Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) has become the first drug to be approved by the US Food and Drug Administration (FDA) as a treatment for noncirrhotic nonalcoholic ...
Akero Therapeutics announced statistically significant results from a Phase 2b trial of efruxifermin this week, a fibroblast ...
but US biotech Madrigal Pharma thinks it now has enough evidence for its drug resmetirom to support regulatory filings. The Massachusetts company has reported the results of the phase 3 MAESTRO ...
Resmetirom has received Breakthrough Therapy designation from the FDA and could be the first approved treatment for patients with NASH with liver fibrosis. Dr. Stephen Harrison, the lead ...
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...
Rezdiffra (resmetirom), a once-daily, oral and liver-directed THR-β agonist. Rezdiffra gained the FDA’s accelerated approval in March 2024 for adult patients with nonalcoholic steatohepatitis ...
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used ...