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Madrigal Pharmaceuticals, Inc.

http://www.madrigalpharma.com/

Latest From Madrigal Pharmaceuticals, Inc.

Drug Candidates For NASH & Epilepsy Disorder Secure EMA PRIME Designations

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.

Europe Research & Development

Madrigal Shows Confidence As It Awaits FDA’s March Decision On Resmetirom

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.

Launches Pricing Strategies

Breakthrough Bounceback Looks Unlikely At US FDA’s CDER, But CBER Is Riding Wave Of RMATs

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.

Review Pathway Approvals

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.

Europe Review Pathway
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Company Information

  • Other Names / Subsidiaries
    • Via Pharmaceuticals, Inc.
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