Hosted on MSN10mon
FDA approves Madrigal’s Rezdiffra as the first NASH therapyMadrigal 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 ...
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 ...
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 ...
Hosted on MSN11mon
Breakthrough in Liver Disease Treatments: Madrigal's Resmetirom Aims to Be the First Approved NASH TherapyResmetirom 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 ...
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 ...
Madrigal Pharma has become the first drugmaker to claim FDA approval for a drug to treat ... s oral THR β-selective agonist Rezdiffra (resmetirom) for adults with MASH – also known as non ...
The FDA approved a wide range of therapies in 2024, including many new molecular entities and biological products.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback