Madrigal Pharmaceuticals, Inc.
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Latest From Madrigal Pharmaceuticals, Inc.
The developers of survodutide and elsunersen will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
With a 14 March FDA action date and no advisory panel scheduled, Madrigal is looking ahead to resmetirom becoming the first approved NASH therapy, following stumbles by competitors.
Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.
EMA Considers Accelerated Review Of Madrigal’s NASH Drug Filing, Discloses Other Fast-Track Decisions
Resmetirom, for noncirrhotic non-alcoholic steatohepatitis, is among the investigational products that the European Medicines Agency has been considering for review under its accelerated assessment pathway.
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